First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

Non-small Cell Lung Cancer Clinical Trial

Official title: Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors (TROPION-PanTumor01)

Status Recruiting

Clinical Trial Summary

This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study.

The primary purpose of the parts are:

• Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a

• Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional solid tumors

This study is expected to last approximately 6 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan.

The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless:

• they withdraw

• their disease gets worse

• they experience unacceptable side effects.

The primary purpose of the sub-study is to compare the effectiveness of steroid versus non-steroid mouthwash as prophylaxis against oral mucositis/stomatitis in participants receiving DS-1062a.

The sub-study is a randomized study that will include approximately 76 participants enrolling into the Dose Expansion part.

Clinical Trial Description

The dosage strength will change during the study but all participants will receive the same study drug. So the study is not a true 2-arm study, it is a 2-part study.

In both parts, participants with pathologically documented unresectable advanced NSCLC and triple negative breast cancer (TNBC) who have been refractory to or relapsed from standard treatment or for which no standard treatment is available, will be enrolled. In Dose Expansion, additional indications (hormone receptor [HR]-positive human epidermal growth factor receptor 2 [HER2]-negative breast cancer, HR-positive HER2-low breast cancer, HER2-positive breast cancer, small cell lung cancer [SCLC], endometrial cancer, pancreatic adenocarcinoma, HER2-negative gastric/gastroesophageal junction [GEJ] cancer, esophageal cancer, head and neck squamous cell carcinoma [HNSCC], transitional cell carcinoma of the urothelium, colorectal cancer [CRC], platinum-resistant ovarian cancer, platinum-sensitive ovarian cancer, cervical cancer, and castration-resistant prostate cancer [CRPC]) may be evaluated, if the study treatment demonstrates acceptable safety, tolerability and efficacy in NSCLC participants. After the primary analysis, the main (registered) study will be considered complete, but data will be collected from participants who continue receiving study drug.

In the sub-study, the additional indications listed for Dose Expansion (except for head and neck cancer) may be evaluated. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Hormone Receptor Positive Breast Cancer
• Non-small Cell Lung Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

• NCT number: NCT03401385
• Study type: Interventional
• Source: Daiichi Sankyo, Inc.
• Contact: (For Asia sites only) Daiichi Sankyo Contact for Clinical Trial
• Phone: +81-3-6225-1111(M-F 9-5 JST)
• Email: dsclinicaltrial@daiichisankyo.co.jp
• Status: Recruiting
• Phase: Phase 1
• Start date: January 31, 2018
• Completion date: January 1, 2025