A Study of D3S-001 Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors With a KRAS p.G12C Mutation

Conditions

• KRAS P.G12C

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• D3S-001 — DRUG
  Oral
• Pembrolizumab — DRUG
  Intravenous
• Cisplatin — DRUG
  Intravenous
• Carboplatin — DRUG
  Intravenous
• Pemetrexed — DRUG
  Intravenous
• Cetuximab — DRUG
  Intravenous

Study Details

This is a first-in-human (FIH), multicenter, open-label, dose-escalation, and dose-expansion Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of D3S-001 or combination therapy in subjects with advanced KRAS p.G12C mutant solid tumors. D3S-001 will be taken daily by oral administration in 21-day treatment cycles.

Key Dates

Start date

Aug 3, 2022

Status verified

Mar 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

442 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: D3S-001 monotherapy
  Part 1: Dose Escalation, D3S-001 administered orally. Part 2 and Part 3a Arm C: Dose Expansion, D3S-001 administered orally in selected cancer type patients. Part 4a: Dose Optimization, D3S-001 administered orally in selected cancer type patients.
• Experimental: D3S-001 and pembrolizumab
  Part 3a Arm A: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients. Pembrolizumab administered intravenously.
• Experimental: D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + pemetrexed)
  Part 3a Arm B: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients. Cisplatin + pemetrexed administered intravenously or Carboplatin + pemetrexed administered intravenously
• Experimental: D3S-001 and Cetuximab
  Part 3b: Dose Expansion, D3S-001 in combination therapy administered orally in selected cancer type patients. Cetuximab administered intravenously.

Primary Outcome Measure

Number of Participants With Adverse Events (AEs) [ Time Frame: From first dose until 30 days after the last dose (or specified in the protocol). ]

Central Contacts

• Medical Director
  +86 21 61635900
  [email protected]

Locations (7)

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