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

Active:	Yes
Cancer Type:	Breast Cancer Cervical Cancer Colon/Rectal Cancer Esophogeal Cancer Lung Cancer Ovarian Cancer Stomach/ Gastric Cancer	NCT ID:	NCT03401385
Trial Phases:	Phase I	Protocol IDs:	DS1062-A-J101 (primary) NCI-2018-01200 173812
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Daiichi Sankyo Inc
NCI Full Details:	http://clinicaltrials.gov/show/NCT03401385

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.

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.