DR-0202 for Advanced Cancer
Recruiting at 9 trial locations
DB
Overseen ByDren Bio Central Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Dren Bio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
A phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas
Research Team
WJ
Wan Jen Hong, MD
Principal Investigator
Dren Bio
Eligibility Criteria
This trial is for adults with various advanced or metastatic cancers that have come back or didn't respond to treatment. Specific types include breast, endometrial, bladder, gastroesophageal junction, thyroid, lung (non-small cell), squamous cell carcinoma of the head and neck region including throat cancer, cervical, ovarian, stomach, prostate and pancreatic cancers.Inclusion Criteria
Willing to provide archival tumor tissue samples or agree to a baseline biopsy
Radiographically measurable disease
Life expectancy of ≥ 3 months
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Exclusion Criteria
Abnormal ECG or myocardial infarction within 6 months prior to C1D1
Significant, uncontrolled concomitant disease
QT interval for heart rate using Fridericia's formula (QTcF) > 480 msec or history of additional risk factors for Torsades de Pointes
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation/Expansion
Participants receive varying doses of DR-0202 every 2 weeks until progression or withdrawal
Expected to be an average of 1 year
Bi-weekly visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- DR-0202
Trial Overview The study tests DR-0202's safety and effectiveness in patients with certain carcinomas. It's a phase 1a/1b trial involving multiple centers where participants receive escalating doses of DR-0202 to find the right balance between safety and activity against cancer.
Participant Groups
8Treatment groups
Experimental Treatment
Group I: DL8 of DR-0202Experimental Treatment1 Intervention
Participants in this arm will receive DL8 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Group II: DL7 of DR-0202Experimental Treatment1 Intervention
Participants in this arm will receive DL7 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Group III: DL6 of DR-0202Experimental Treatment1 Intervention
Participants in this arm will receive DL6 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Group IV: DL5 of DR-0202Experimental Treatment1 Intervention
Participants in this arm will receive DL5 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Group V: DL4 of DR-0202Experimental Treatment1 Intervention
Participants in this arm will receive DL4 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Group VI: DL3 of DR-0202Experimental Treatment1 Intervention
Participants in this arm will receive DL3 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Group VII: DL2 of DR-0202Experimental Treatment1 Intervention
Participants in this arm will receive DL2 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Group VIII: DL1 of DR-0202Experimental Treatment1 Intervention
Participants in this arm will receive DL1 milligrams of DR-0202 every 2 weeks until progression or withdrawal
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dren Bio
Lead Sponsor
Trials
6
Recruited
280+
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