Description:
This study is in one single group of participants with advanced solid tumors who have not
been cured by other treatments. It is the first time the drug will be used in humans, and
will be in two parts.
The primary purpose of the parts are:
- Dose Escalation Part: To evaluate the safety and tolerability and to determine the
maximum tolerated dose and the recommended dose for expansion of DS-7300a.
- Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of
DS-7300a.
This study is expected to last approximately 3.5 years from the time the first participant is
enrolled to the time the last participant is off the study.
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.
Title
- Brief Title: Study of DS-7300a in Participants With Advanced Solid Malignant Tumors
- Official Title: Phase I/II, Two-Part, Multicenter First-in-Human Study of DS-7300a in Subjects With Advanced Solid Malignant Tumors
Clinical Trial IDs
- ORG STUDY ID:
DS7300-A-J101
- SECONDARY ID:
194992
- NCT ID:
NCT04145622
Conditions
- Advanced Solid Tumor
- Malignant Solid Tumor
Interventions
Drug | Synonyms | Arms |
---|
DS-7300a | | Dose escalation |
Purpose
This study is in one single group of participants with advanced solid tumors who have not
been cured by other treatments. It is the first time the drug will be used in humans, and
will be in two parts.
The primary purpose of the parts are:
- Dose Escalation Part: To evaluate the safety and tolerability and to determine the
maximum tolerated dose and the recommended dose for expansion of DS-7300a.
- Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of
DS-7300a.
This study is expected to last approximately 3.5 years from the time the first participant is
enrolled to the time the last participant is off the study.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose escalation | Experimental | All participants enrolled in the dose escalation part | |
Dose expansion | Experimental | All participants enrolled in the dose expansion part | |
Eligibility Criteria
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
- Has at least 1 measurable lesion according to Response Evaluation Criteria in Solid
Tumors (RECIST) Version 1.1.
- Has adequate cardiac, hematopoietic, renal and hepatic functions
- Has an adequate treatment washout period prior to start of study treatment
Additional Inclusion Criteria for Part 1 (Dose Escalation)
- Has a pathologically documented advanced/unresectable or metastatic head and neck
squamous cell carcinoma, esophageal squamous cell carcinoma, squamous and
adenocarcinoma non-small cell lung cancer (NSCLC), bladder cancer, sarcoma,
endometrial cancer, melanoma, prostate cancer, breast cancer that is refractory to or
intolerable with standard treatment, or for which no standard treatment is available.
Additional Inclusion Criteria for Part 2 (Dose Expansion)
- Has a pathologically documented advanced/unresectable or metastatic head and neck
squamous cell carcinoma, esophageal squamous cell carcinoma, squamous-NSCLC that is
refractory to or intolerable with standard treatment, or for which no standard
treatment is available. Additional or alternative indications may be added to
expansion cohorts based on preliminary signals of activity in dose escalation via a
protocol amendment.
Exclusion Criteria:
- Has prior treatment with B7-H3 targeted agent.
- Has prior treatment with an antibody drug conjugate that consists of an exatecan
derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan).
- Has multiple primary malignancies, except adequately resected non-melanoma skin
cancer, curatively treated in situ disease, or other solid tumors curatively treated,
with no evidence of disease for ≥3 years.
- Has a medical history of myocardial infarction, symptomatic congestive heart failure
(CHF) (New York Heart Association classes II-IV), unstable angina or serious cardiac
arrhythmia.
- Has an uncontrolled infection requiring systemic therapy.
- Has clinically significant pulmonary compromise or requirement for supplemental
oxygen.
- Has substance abuse or any other medical conditions that would increase the safety
risk to the subject or interfere with participation of the subject or evaluation of
the clinical study in the opinion of the Investigator.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Evaluate the incidence of dose-limiting toxicities (DLTs) |
Time Frame: | Day 1 to Day 21 in Cycle 1 in the dose escalation part |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Characterize the PK parameter AUClast |
Time Frame: | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) |
Safety Issue: | |
Description: | |
Measure: | Characterize the PK parameter AUCtau |
Time Frame: | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) |
Safety Issue: | |
Description: | |
Measure: | Characterize the PK parameter Cmax |
Time Frame: | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) |
Safety Issue: | |
Description: | |
Measure: | Characterize the PK parameter Tmax |
Time Frame: | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) |
Safety Issue: | |
Description: | |
Measure: | Characterize the PK parameter Ctrough |
Time Frame: | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) |
Safety Issue: | |
Description: | |
Measure: | Assess the incidence of anti-drug antibodies (ADAs) |
Time Frame: | Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Daiichi Sankyo Co., Ltd. |
Trial Keywords
- Advanced Solid Tumor
- Malignant Tumor
- DS-7300a
Last Updated
August 23, 2021