Health Trials

A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

ConditionsTriple Negative Breast CancerHER2-negative Breast CancerNon Small Cell Lung CancerCervical CancerCastrate Resistant Prostate CancerPancreatic Ductal AdenocarcinomaHead-and-neck Squamous Cell CarcinomaEndometrial CancerOvarian CancerGastric CancerGastroesophageal-junction CancerUrothelial Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDren Bio

About 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

Eligibility criteria

Qualifiers

Histologically confirmed epithelial cancer of the following tumor types: breast (TNBC, HR+/HER2-/+BC), NSCLC, cervical, CRPC, PDAC, HNSCC, endometrial, ovarian, gastric/GEJ, or urothelial that is unresectable, locally advanced or metastatic

Relapsed or refractory with at least 2 prior lines of therapy and for which no standard of care treatment options are available

Radiographically measurable disease

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Disqualifiers

Major surgery within 28 days prior to Day 1

Systemic chemotherapy and anticancer therapies within 4 weeks or 5 half-lives of the drug, whichever is shorter.

Antibody-based anticancer therapy: ≥ 4 weeks. Note: Treatment with systemic corticosteroids ≤ 25 mg/day (prednisone or equivalent) and inhaled or topical steroids are allowed. For participants with CRPC, LHRH agents are allowed.

Radiation therapy within 21 days prior to C1D1. Palliative radiation therapy may be allowed following discussion with Medical Monitor

Trial design

Treatments tested in this trial

  • DR-0202

Treatment groups

96 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Locations

10
Colorado
Dren Investigational Site80218, Denver United States
Florida
Dren Investigational Site32827, Orlando United States
Dren Investigational Site34232, Sarasota United States
North Carolina
Dren Investigational Site28078, Huntersville United States

Sponsors and collaborators

Dren Bio

Lead sponsor

Source ClinicalTrials.gov