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First-in-human, phase I/IIa study of CRLX301, a nanoparticle drug conjugate containing docetaxel, in patients with advanced or metastatic solid malignancies.

Investigational new drugs

Piha-Paul SA, Thein KZ, De Souza P, Kefford R, Gangadhar T, Smith C, Schuster S, Zamboni WC, Dees CE, Markman B.
PMID: 33594602
Invest New Drugs. 2021 Aug;39(4):1047-1056. doi: 10.1007/s10637-021-01081-x. Epub 2021 Feb 16.

Background This was a phase I/IIa study to investigate the tolerability, efficacy and pharmacokinetics (PK)/ pharmacodynamics (PD) of CRLX301, CDP-based nanoparticle formulation of docetaxel. Methods The study was conducted in two parts. In part 1, dose-escalation using a standard...

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Piha-Paul SA, Thein KZ, De Souza P, et al. First-in-human, phase I/IIa study of CRLX301, a nanoparticle drug conjugate containing docetaxel, in patients with advanced or metastatic solid malignancies. Invest New Drugs. 2021;39(4):1047-1056doi: 10.1007/s10637-021-01081-x.
Piha-Paul, S. A., Thein, K. Z., De Souza, P., Kefford, R., Gangadhar, T., Smith, C., Schuster, S., Zamboni, W. C., Dees, C. E., & Markman, B. (2021). First-in-human, phase I/IIa study of CRLX301, a nanoparticle drug conjugate containing docetaxel, in patients with advanced or metastatic solid malignancies. Investigational new drugs, 39(4), 1047-1056. https://doi.org/10.1007/s10637-021-01081-x
Piha-Paul, Sarina A, et al. "First-in-human, phase I/IIa study of CRLX301, a nanoparticle drug conjugate containing docetaxel, in patients with advanced or metastatic solid malignancies." Investigational new drugs vol. 39,4 (2021): 1047-1056. doi: https://doi.org/10.1007/s10637-021-01081-x
Piha-Paul SA, Thein KZ, De Souza P, Kefford R, Gangadhar T, Smith C, Schuster S, Zamboni WC, Dees CE, Markman B. First-in-human, phase I/IIa study of CRLX301, a nanoparticle drug conjugate containing docetaxel, in patients with advanced or metastatic solid malignancies. Invest New Drugs. 2021 Aug;39(4):1047-1056. doi: 10.1007/s10637-021-01081-x. Epub 2021 Feb 16. PMID: 33594602.
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Correction to: Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study.

Investigational new drugs

Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Zarifa A, Shah J, Milton DR, Bean S, McQuinn L, Gong J, Colen R, Carter BW, Subbiah V, Ogbonna DC, Pant S, Meric-Bernstam F, Naing A.
PMID: 34705134
Invest New Drugs. 2021 Oct 27; doi: 10.1007/s10637-021-01192-5. Epub 2021 Oct 27.

No abstract available.

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Thein KZ, Piha-Paul SA, Tsimberidou A, et al. Correction to: Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study. Invest New Drugs. 2021;doi: 10.1007/s10637-021-01192-5.
Thein, K. Z., Piha-Paul, S. A., Tsimberidou, A., Karp, D. D., Janku, F., Zarifa, A., Shah, J., Milton, D. R., Bean, S., McQuinn, L., Gong, J., Colen, R., Carter, B. W., Subbiah, V., Ogbonna, D. C., Pant, S., Meric-Bernstam, F., & Naing, A. (2021). Correction to: Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study. Investigational new drugs, . https://doi.org/10.1007/s10637-021-01192-5
Thein, Kyaw Zin, et al. "Correction to: Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study." Investigational new drugs vol. (2021). doi: https://doi.org/10.1007/s10637-021-01192-5
Thein KZ, Piha-Paul SA, Tsimberidou A, Karp DD, Janku F, Zarifa A, Shah J, Milton DR, Bean S, McQuinn L, Gong J, Colen R, Carter BW, Subbiah V, Ogbonna DC, Pant S, Meric-Bernstam F, Naing A. Correction to: Selinexor in combination with topotecan in patients with advanced or metastatic solid tumors: Results of an open-label, single-center, multi-arm phase Ib study. Invest New Drugs. 2021 Oct 27; doi: 10.1007/s10637-021-01192-5. Epub 2021 Oct 27. PMID: 34705134.
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TAS-119, a novel selective Aurora A and TRK inhibitor, exhibits antitumor efficacy in preclinical models with deregulated activation of the Myc, β-Catenin, and TRK pathways.

Investigational new drugs

Miura A, Sootome H, Fujita N, Suzuki T, Fukushima H, Mizuarai S, Masuko N, Ito K, Hashimoto A, Uto Y, Sugimoto T, Takahashi H, Mitsuya M, Hirai H.
PMID: 33409897
Invest New Drugs. 2021 Jun;39(3):724-735. doi: 10.1007/s10637-020-01019-9. Epub 2021 Jan 06.

Aurora kinase A, a mitotic kinase that is overexpressed in various cancers, is a promising cancer drug target. Here, we performed preclinical characterization of TAS-119, a novel, orally active, and highly selective inhibitor of Aurora A. TAS-119 showed strong...

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Miura A, Sootome H, Fujita N, et al. TAS-119, a novel selective Aurora A and TRK inhibitor, exhibits antitumor efficacy in preclinical models with deregulated activation of the Myc, β-Catenin, and TRK pathways. Invest New Drugs. 2021;39(3):724-735doi: 10.1007/s10637-020-01019-9.
Miura, A., Sootome, H., Fujita, N., Suzuki, T., Fukushima, H., Mizuarai, S., Masuko, N., Ito, K., Hashimoto, A., Uto, Y., Sugimoto, T., Takahashi, H., Mitsuya, M., & Hirai, H. (2021). TAS-119, a novel selective Aurora A and TRK inhibitor, exhibits antitumor efficacy in preclinical models with deregulated activation of the Myc, β-Catenin, and TRK pathways. Investigational new drugs, 39(3), 724-735. https://doi.org/10.1007/s10637-020-01019-9
Miura, Akihiro, et al. "TAS-119, a novel selective Aurora A and TRK inhibitor, exhibits antitumor efficacy in preclinical models with deregulated activation of the Myc, β-Catenin, and TRK pathways." Investigational new drugs vol. 39,3 (2021): 724-735. doi: https://doi.org/10.1007/s10637-020-01019-9
Miura A, Sootome H, Fujita N, Suzuki T, Fukushima H, Mizuarai S, Masuko N, Ito K, Hashimoto A, Uto Y, Sugimoto T, Takahashi H, Mitsuya M, Hirai H. TAS-119, a novel selective Aurora A and TRK inhibitor, exhibits antitumor efficacy in preclinical models with deregulated activation of the Myc, β-Catenin, and TRK pathways. Invest New Drugs. 2021 Jun;39(3):724-735. doi: 10.1007/s10637-020-01019-9. Epub 2021 Jan 06. PMID: 33409897.
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Relapsing polychondritis after treatment with PD-1 blockade.

Investigational new drugs

Ogimoto T, Yoshida H, Mizuta M, Hirai T.
PMID: 34562229
Invest New Drugs. 2021 Sep 25; doi: 10.1007/s10637-021-01186-3. Epub 2021 Sep 25.

Nivolumab, a programmed death 1 blockade drug, is used in various types of cancers and can cause a unique immune-related adverse event (irAE). Relapsing polychondritis (RP) is a rare autoimmune disease that mainly involves inflammation of the auricle, nose...

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Ogimoto T, Yoshida H, Mizuta M, et al. Relapsing polychondritis after treatment with PD-1 blockade. Invest New Drugs. 2021;doi: 10.1007/s10637-021-01186-3.
Ogimoto, T., Yoshida, H., Mizuta, M., & Hirai, T. (2021). Relapsing polychondritis after treatment with PD-1 blockade. Investigational new drugs, . https://doi.org/10.1007/s10637-021-01186-3
Ogimoto, Tatsuya, et al. "Relapsing polychondritis after treatment with PD-1 blockade." Investigational new drugs vol. (2021). doi: https://doi.org/10.1007/s10637-021-01186-3
Ogimoto T, Yoshida H, Mizuta M, Hirai T. Relapsing polychondritis after treatment with PD-1 blockade. Invest New Drugs. 2021 Sep 25; doi: 10.1007/s10637-021-01186-3. Epub 2021 Sep 25. PMID: 34562229.
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Zerumbone acts as a radiosensitizer in head and neck squamous cell carcinoma.

Investigational new drugs

Schnoell J, Stanisz I, Jank BJ, Stanek V, Schmid R, Brunner M, Heiduschka G, Kotowski U.
PMID: 34613571
Invest New Drugs. 2021 Oct 06; doi: 10.1007/s10637-021-01190-7. Epub 2021 Oct 06.

INTRODUCTION: Zerumbone is a phytochemical compound of the ginger plant Zingiber zerumbet with cytotoxic effects in various cancer cell lines. To date, zerumbone has shown an antiproliferative effect in oral squamous cell carcinoma cells lines. However, the effect of...

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Schnoell J, Stanisz I, Jank BJ, et al. Zerumbone acts as a radiosensitizer in head and neck squamous cell carcinoma. Invest New Drugs. 2021;doi: 10.1007/s10637-021-01190-7.
Schnoell, J., Stanisz, I., Jank, B. J., Stanek, V., Schmid, R., Brunner, M., Heiduschka, G., & Kotowski, U. (2021). Zerumbone acts as a radiosensitizer in head and neck squamous cell carcinoma. Investigational new drugs, . https://doi.org/10.1007/s10637-021-01190-7
Schnoell, Julia, et al. "Zerumbone acts as a radiosensitizer in head and neck squamous cell carcinoma." Investigational new drugs vol. (2021). doi: https://doi.org/10.1007/s10637-021-01190-7
Schnoell J, Stanisz I, Jank BJ, Stanek V, Schmid R, Brunner M, Heiduschka G, Kotowski U. Zerumbone acts as a radiosensitizer in head and neck squamous cell carcinoma. Invest New Drugs. 2021 Oct 06; doi: 10.1007/s10637-021-01190-7. Epub 2021 Oct 06. PMID: 34613571.
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Benzyl and phenethyl isothiocyanates as promising epigenetic drug compounds by modulating histone acetylation and methylation marks in malignant melanoma.

Investigational new drugs

Mitsiogianni M, Anestopoulos I, Kyriakou S, Trafalis DT, Franco R, Pappa A, Panayiotidis MI.
PMID: 33963962
Invest New Drugs. 2021 Dec;39(6):1460-1468. doi: 10.1007/s10637-021-01127-0. Epub 2021 May 08.

Melanoma is an aggressive skin cancer with increasing incidence rates globally. On the other hand, isothiocyanates are derived from cruciferous vegetables and are known to exert a wide range of anti-cancer activities including, among others, their ability to interact...

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Mitsiogianni M, Anestopoulos I, Kyriakou S, et al. Benzyl and phenethyl isothiocyanates as promising epigenetic drug compounds by modulating histone acetylation and methylation marks in malignant melanoma. Invest New Drugs. 2021;39(6):1460-1468doi: 10.1007/s10637-021-01127-0.
Mitsiogianni, M., Anestopoulos, I., Kyriakou, S., Trafalis, D. T., Franco, R., Pappa, A., & Panayiotidis, M. I. (2021). Benzyl and phenethyl isothiocyanates as promising epigenetic drug compounds by modulating histone acetylation and methylation marks in malignant melanoma. Investigational new drugs, 39(6), 1460-1468. https://doi.org/10.1007/s10637-021-01127-0
Mitsiogianni, Melina, et al. "Benzyl and phenethyl isothiocyanates as promising epigenetic drug compounds by modulating histone acetylation and methylation marks in malignant melanoma." Investigational new drugs vol. 39,6 (2021): 1460-1468. doi: https://doi.org/10.1007/s10637-021-01127-0
Mitsiogianni M, Anestopoulos I, Kyriakou S, Trafalis DT, Franco R, Pappa A, Panayiotidis MI. Benzyl and phenethyl isothiocyanates as promising epigenetic drug compounds by modulating histone acetylation and methylation marks in malignant melanoma. Invest New Drugs. 2021 Dec;39(6):1460-1468. doi: 10.1007/s10637-021-01127-0. Epub 2021 May 08. PMID: 33963962.
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Gemcitabine, carboplatin and veliparib in multiple relapsed/refractory germ cell tumours: The GCT-SK-004 phase II trial.

Investigational new drugs

Mego M, Svetlovska D, Reckova M, Angelis, Kalavska K, Obertova J, Palacka P, Rejlekova K, Sycova-Mila Z, Chovanec M, Mardiak J.
PMID: 34052929
Invest New Drugs. 2021 Dec;39(6):1664-1670. doi: 10.1007/s10637-021-01130-5. Epub 2021 May 29.

Background Patients with multiple relapsed/refractory germ cell tumours (GCTs) have an extremely poor prognosis. PARP (poly-ADP-ribose polymerase) is overexpressed in GCTs compared to normal testes, and PARP overexpression is an early event in GCT development. This study aimed to...

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Mego M, Svetlovska D, Reckova M, et al. Gemcitabine, carboplatin and veliparib in multiple relapsed/refractory germ cell tumours: The GCT-SK-004 phase II trial. Invest New Drugs. 2021;39(6):1664-1670doi: 10.1007/s10637-021-01130-5.
Mego, M., Svetlovska, D., Reckova, M., Angelis, Kalavska, K., Obertova, J., Palacka, P., Rejlekova, K., Sycova-Mila, Z., Chovanec, M., & Mardiak, J. (2021). Gemcitabine, carboplatin and veliparib in multiple relapsed/refractory germ cell tumours: The GCT-SK-004 phase II trial. Investigational new drugs, 39(6), 1664-1670. https://doi.org/10.1007/s10637-021-01130-5
Mego, M, et al. "Gemcitabine, carboplatin and veliparib in multiple relapsed/refractory germ cell tumours: The GCT-SK-004 phase II trial." Investigational new drugs vol. 39,6 (2021): 1664-1670. doi: https://doi.org/10.1007/s10637-021-01130-5
Mego M, Svetlovska D, Reckova M, Angelis, Kalavska K, Obertova J, Palacka P, Rejlekova K, Sycova-Mila Z, Chovanec M, Mardiak J. Gemcitabine, carboplatin and veliparib in multiple relapsed/refractory germ cell tumours: The GCT-SK-004 phase II trial. Invest New Drugs. 2021 Dec;39(6):1664-1670. doi: 10.1007/s10637-021-01130-5. Epub 2021 May 29. PMID: 34052929.
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Phase 1a study of the CDK4/6 inhibitor, FCN-437c, in Chinese patients with HR + /HER2- advanced breast cancer.

Investigational new drugs

Zhang J, Wang X, Wang X, Hui A, Wu Z, Tian L, Xu C, Yang Y, Zhang W, Hu X.
PMID: 34109484
Invest New Drugs. 2021 Dec;39(6):1549-1558. doi: 10.1007/s10637-021-01133-2. Epub 2021 Jun 09.

Purpose This phase 1a, first-in-human study assessed the safety, maximum tolerated dose (MTD), pharmacokinetics (PK), and antitumor activity of FCN-437c, a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor. Methods The study enrolled female patients with HR + /HER2- advanced...

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Zhang J, Wang X, Wang X, et al. Phase 1a study of the CDK4/6 inhibitor, FCN-437c, in Chinese patients with HR + /HER2- advanced breast cancer. Invest New Drugs. 2021;39(6):1549-1558doi: 10.1007/s10637-021-01133-2.
Zhang, J., Wang, X., Wang, X., Hui, A., Wu, Z., Tian, L., Xu, C., Yang, Y., Zhang, W., & Hu, X. (2021). Phase 1a study of the CDK4/6 inhibitor, FCN-437c, in Chinese patients with HR + /HER2- advanced breast cancer. Investigational new drugs, 39(6), 1549-1558. https://doi.org/10.1007/s10637-021-01133-2
Zhang, Jian, et al. "Phase 1a study of the CDK4/6 inhibitor, FCN-437c, in Chinese patients with HR + /HER2- advanced breast cancer." Investigational new drugs vol. 39,6 (2021): 1549-1558. doi: https://doi.org/10.1007/s10637-021-01133-2
Zhang J, Wang X, Wang X, Hui A, Wu Z, Tian L, Xu C, Yang Y, Zhang W, Hu X. Phase 1a study of the CDK4/6 inhibitor, FCN-437c, in Chinese patients with HR + /HER2- advanced breast cancer. Invest New Drugs. 2021 Dec;39(6):1549-1558. doi: 10.1007/s10637-021-01133-2. Epub 2021 Jun 09. PMID: 34109484; PMCID: PMC8541945.
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A phase I study of intraperitoneal paclitaxel combined with gemcitabine plus nab-paclitaxel for pancreatic cancer with peritoneal metastasis.

Investigational new drugs

Takahara N, Nakai Y, Ishigami H, Saito K, Sato T, Hakuta R, Ishigaki K, Saito T, Hamada T, Mizuno S, Kogure H, Yamashita H, Isayama H, Seto Y, Koike K.
PMID: 32772340
Invest New Drugs. 2021 Feb;39(1):175-181. doi: 10.1007/s10637-020-00982-7. Epub 2020 Aug 08.

PURPOSE: A phase I study of intraperitoneal paclitaxel (ip PTX) combined with gemcitabine (GEM) plus nab-paclitaxel (nab-PTX) (GnP) was conducted to determine the maximum tolerated dose (MTD) and the recommended dose (RD) in pancreatic cancer patients with peritoneal metastasis...

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Takahara N, Nakai Y, Ishigami H, et al. A phase I study of intraperitoneal paclitaxel combined with gemcitabine plus nab-paclitaxel for pancreatic cancer with peritoneal metastasis. Invest New Drugs. 2020;39(1):175-181doi: 10.1007/s10637-020-00982-7.
Takahara, N., Nakai, Y., Ishigami, H., Saito, K., Sato, T., Hakuta, R., Ishigaki, K., Saito, T., Hamada, T., Mizuno, S., Kogure, H., Yamashita, H., Isayama, H., Seto, Y., & Koike, K. (2021). A phase I study of intraperitoneal paclitaxel combined with gemcitabine plus nab-paclitaxel for pancreatic cancer with peritoneal metastasis. Investigational new drugs, 39(1), 175-181. https://doi.org/10.1007/s10637-020-00982-7
Takahara, Naminatsu, et al. "A phase I study of intraperitoneal paclitaxel combined with gemcitabine plus nab-paclitaxel for pancreatic cancer with peritoneal metastasis." Investigational new drugs vol. 39,1 (2021): 175-181. doi: https://doi.org/10.1007/s10637-020-00982-7
Takahara N, Nakai Y, Ishigami H, Saito K, Sato T, Hakuta R, Ishigaki K, Saito T, Hamada T, Mizuno S, Kogure H, Yamashita H, Isayama H, Seto Y, Koike K. A phase I study of intraperitoneal paclitaxel combined with gemcitabine plus nab-paclitaxel for pancreatic cancer with peritoneal metastasis. Invest New Drugs. 2021 Feb;39(1):175-181. doi: 10.1007/s10637-020-00982-7. Epub 2020 Aug 08. PMID: 32772340.
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Dual-function chimeric antigen receptor T cells targeting c-Met and PD-1 exhibit potent anti-tumor efficacy in solid tumors.

Investigational new drugs

Yuan X, Sun Z, Yuan Q, Hou W, Liang Q, Wang Y, Mo W, Wang H, Yu M.
PMID: 32772342
Invest New Drugs. 2021 Feb;39(1):34-51. doi: 10.1007/s10637-020-00978-3. Epub 2020 Aug 08.

Purpose Programmed cell death 1 (PD-1), which is upregulated under the continuous induction of the tumor microenvironment, causes chimeric antigen receptor (CAR)-T cell hypofunction via interaction with programmed death ligand 1 (PD-L1). This study aimed to construct CAR-T cells...

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Yuan X, Sun Z, Yuan Q, et al. Dual-function chimeric antigen receptor T cells targeting c-Met and PD-1 exhibit potent anti-tumor efficacy in solid tumors. Invest New Drugs. 2020;39(1):34-51doi: 10.1007/s10637-020-00978-3.
Yuan, X., Sun, Z., Yuan, Q., Hou, W., Liang, Q., Wang, Y., Mo, W., Wang, H., & Yu, M. (2021). Dual-function chimeric antigen receptor T cells targeting c-Met and PD-1 exhibit potent anti-tumor efficacy in solid tumors. Investigational new drugs, 39(1), 34-51. https://doi.org/10.1007/s10637-020-00978-3
Yuan, Xingxing, et al. "Dual-function chimeric antigen receptor T cells targeting c-Met and PD-1 exhibit potent anti-tumor efficacy in solid tumors." Investigational new drugs vol. 39,1 (2021): 34-51. doi: https://doi.org/10.1007/s10637-020-00978-3
Yuan X, Sun Z, Yuan Q, Hou W, Liang Q, Wang Y, Mo W, Wang H, Yu M. Dual-function chimeric antigen receptor T cells targeting c-Met and PD-1 exhibit potent anti-tumor efficacy in solid tumors. Invest New Drugs. 2021 Feb;39(1):34-51. doi: 10.1007/s10637-020-00978-3. Epub 2020 Aug 08. PMID: 32772342.
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Erlotinib and bevacizumab in elderly patients ≥75 years old with non-small cell lung cancer harboring epidermal growth factor receptor mutations.

Investigational new drugs

Aoshima Y, Karayama M, Inui N, Yasui H, Hozumi H, Suzuki Y, Furuhashi K, Fujisawa T, Enomoto N, Nakamura Y, Mikamo M, Matsuura S, Kusagaya H, Kaida Y, Uto T, Hashimoto D, Matsui T, Asada K, Suda T.
PMID: 32803701
Invest New Drugs. 2021 Feb;39(1):210-216. doi: 10.1007/s10637-020-00988-1. Epub 2020 Aug 17.

The efficacy and safety of combination therapy with erlotinib and bevacizumab in elderly patients with non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) gene mutations are unknown. Elderly patients aged ≥75 years old with advanced or recurrent...

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Aoshima Y, Karayama M, Inui N, et al. Erlotinib and bevacizumab in elderly patients ≥75 years old with non-small cell lung cancer harboring epidermal growth factor receptor mutations. Invest New Drugs. 2020;39(1):210-216doi: 10.1007/s10637-020-00988-1.
Aoshima, Y., Karayama, M., Inui, N., Yasui, H., Hozumi, H., Suzuki, Y., Furuhashi, K., Fujisawa, T., Enomoto, N., Nakamura, Y., Mikamo, M., Matsuura, S., Kusagaya, H., Kaida, Y., Uto, T., Hashimoto, D., Matsui, T., Asada, K., & Suda, T. (2021). Erlotinib and bevacizumab in elderly patients ≥75 years old with non-small cell lung cancer harboring epidermal growth factor receptor mutations. Investigational new drugs, 39(1), 210-216. https://doi.org/10.1007/s10637-020-00988-1
Aoshima, Yoichiro, et al. "Erlotinib and bevacizumab in elderly patients ≥75 years old with non-small cell lung cancer harboring epidermal growth factor receptor mutations." Investigational new drugs vol. 39,1 (2021): 210-216. doi: https://doi.org/10.1007/s10637-020-00988-1
Aoshima Y, Karayama M, Inui N, Yasui H, Hozumi H, Suzuki Y, Furuhashi K, Fujisawa T, Enomoto N, Nakamura Y, Mikamo M, Matsuura S, Kusagaya H, Kaida Y, Uto T, Hashimoto D, Matsui T, Asada K, Suda T. Erlotinib and bevacizumab in elderly patients ≥75 years old with non-small cell lung cancer harboring epidermal growth factor receptor mutations. Invest New Drugs. 2021 Feb;39(1):210-216. doi: 10.1007/s10637-020-00988-1. Epub 2020 Aug 17. PMID: 32803701.
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First-in-human evaluation of the novel mitochondrial complex I inhibitor ASP4132 for treatment of cancer.

Investigational new drugs

Janku F, LoRusso P, Mansfield AS, Nanda R, Spira A, Wang T, Melhem-Bertrandt A, Sugg J, Ball HA.
PMID: 33830407
Invest New Drugs. 2021 Oct;39(5):1348-1356. doi: 10.1007/s10637-021-01112-7. Epub 2021 Apr 08.

Background We assessed the safety, tolerability, and pharmacokinetics of mitochondrial complex 1 inhibitor ASP4132. Methods This phase I dose-escalation/dose-expansion study enrolled patients with treatment refractory advanced solid tumors to assess safety, dose-limiting toxicities (DLTs), efficacy and pharmacokinetic or oral...

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Janku F, LoRusso P, Mansfield AS, et al. First-in-human evaluation of the novel mitochondrial complex I inhibitor ASP4132 for treatment of cancer. Invest New Drugs. 2021;39(5):1348-1356doi: 10.1007/s10637-021-01112-7.
Janku, F., LoRusso, P., Mansfield, A. S., Nanda, R., Spira, A., Wang, T., Melhem-Bertrandt, A., Sugg, J., & Ball, H. A. (2021). First-in-human evaluation of the novel mitochondrial complex I inhibitor ASP4132 for treatment of cancer. Investigational new drugs, 39(5), 1348-1356. https://doi.org/10.1007/s10637-021-01112-7
Janku, Filip, et al. "First-in-human evaluation of the novel mitochondrial complex I inhibitor ASP4132 for treatment of cancer." Investigational new drugs vol. 39,5 (2021): 1348-1356. doi: https://doi.org/10.1007/s10637-021-01112-7
Janku F, LoRusso P, Mansfield AS, Nanda R, Spira A, Wang T, Melhem-Bertrandt A, Sugg J, Ball HA. First-in-human evaluation of the novel mitochondrial complex I inhibitor ASP4132 for treatment of cancer. Invest New Drugs. 2021 Oct;39(5):1348-1356. doi: 10.1007/s10637-021-01112-7. Epub 2021 Apr 08. PMID: 33830407.
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Showing 13 to 24 of 318 entries