Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

Conditions

• Breast Adenocarcinoma
• Endometrial Cancer
• Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)
• Fallopian Tube Cancer
• High Grade Epithelial Ovarian Cancer
• High Grade Serous Ovarian Cancer
• Hormone Receptor-positive/Her2 Negative Breast Cancer
• Mesothelioma
• Non-small Cell Lung Cancer
• Platinum Sensitive Ovarian Cancer (PSOC)
• Platinum-resistant Ovarian Cancer (PROC)
• Primary Peritoneal Carcinoma
• Primary Refractory Ovarian Cancer
• Triple Negative Breast Cancer
• Uterine Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rina-S — DRUG
  Intravenous infusion of Rina-S
• Carboplatin — DRUG
  Carboplatin intravenous infusion
• Bevacizumab — DRUG
  Bevacizumab intravenous infusion
• Pembrolizumab — DRUG
  Pembrolizumab intravenous infusion

Study Details

This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).

Key Dates

Start date

Dec 7, 2022

Status verified

Jun 2026

Primary completion

Jul 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

884 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part A, B, C, E, F, G, H, I, J and K
  Rina-S monotherapy in Part A and at the recommended dose in Parts B, C, E, F, G, H, I, J and K.
• Experimental: Part D1
  Rina-S in combination with carboplatin
• Experimental: Part D2 and I
  Rina-S in combination with bevacizumab
• Experimental: Part D3 and D4
  Rina-S in combination with pembrolizumab

Primary Outcome Measure

Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] [ Time Frame: Through end of treatment, up to approximately 1 year. ]

Central Contacts

• Genmab Trial Information
  +4570202728
  [email protected]

Locations (37)

Find similar trials in Phoenix, AZ

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