A Phase 1/2 Study of D3S-002 as Monotherapy or Combination Therapy in Adult Subjects With Advanced Solid Tumors With MAPK Pathway Mutations

Conditions

• Advanced Solid Tumors With MAPK Pathway Mutations

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• D3S-002 — DRUG
  Oral Tablet
• D3S-001 — DRUG
  Oral Capsule

Study Details

This first-in-human (FIH) study aims to assess the safety, tolerability, pharmacokinetics, and recommended phase 2 dose (RP2D) of D3S-002 given orally daily for 21-day cycles in adult subjects with advanced solid tumors with mitogen-activated protein kinase (MAPK) pathway mutations.

Key Dates

Start date

Jul 10, 2023

Status verified

Jun 2026

Primary completion

Aug 31, 2028

Completion

Aug 31, 2028

Study Design

Enrollment

67 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: D3S-002 Monotherapy
  Part 1: Dose Escalation, D3S-002 administered orally.
• Experimental: D3S-002 and D3S-001 Combination Therapy
  Part 2a: Dose Escalation, D3S-002 and D3S-001 administered orally. Part 2b: Dose Expansion, D3S-002 and D3S-001 administered orally.

Primary Outcome Measure

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

Central Contacts

• Medical Director
  +86 21 61635900
  [email protected]

Locations (3)

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