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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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • DR-0202

    Drug

    DR-0202 is a bispecific antibody

Treatment groups

96 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: DL1 of DR-0202Experimental treatment 1 intervention
Group B: DL2 of DR-0202Experimental treatment 1 intervention
Group C: DL3 of DR-0202Experimental treatment 1 intervention
Group D: DL4 of DR-0202Experimental treatment 1 intervention
Group E: DL5 of DR-0202Experimental treatment 1 intervention
Group F: DL6 of DR-0202Experimental treatment 1 intervention
Group G: DL7 of DR-0202Experimental treatment 1 intervention
Group H: DL8 of DR-0202Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 during DR-0202 treatment through study completion (Safety and Tolerability)

* Incidence, severity, and relationship of TEAEs (per CTCAE v5.0) through study completion (expected to be an average of 1 year) including but not limited to vital signs, clinical laboratory values (hematology, clinical chemistry, coagulation, urinalysis), 12-lead ECG * Occurrence of DLTs during Cycle 1 (28 days)

Time frame
28-day DLT Period and Treatment Duration / Study Completion

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dren Bio

Lead sponsor

Source ClinicalTrials.gov
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