Health TrialsbyHealthPanel

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

ConditionKRAS P.G12C
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorD3 Bio (Wuxi) Co., Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must have a histologically or cytologically confirmed metastatic or locally advanced solid tumor which is progressing.

Subject must have documented KRAS p.G12C mutation identified within the last 5 years by a local test on tumor tissue or blood.

Subject must have measurable disease per RECIST v1.1.

Subject must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • D3S-001

    Drug

    Oral

  • Pembrolizumab

    Drug

    Intravenous

  • Cisplatin

    Drug

    Intravenous

  • Carboplatin

    Drug

    Intravenous

  • Pemetrexed

    Drug

    Intravenous

  • Cetuximab

    Drug

    Intravenous

Treatment groups

442 Participants
are divided into 4 treatment groups
Group A: D3S-001 monotherapyExperimental treatment 1 intervention
Group B: D3S-001 and pembrolizumabExperimental treatment 2 interventions
Group C: D3S-001 and platinum doublet chemotherapy (cisplatin + pemetrexed or carboplatin + pemetrexed)Experimental treatment 4 interventions
Group D: D3S-001 and CetuximabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants With Adverse Events (AEs)

Time frame
From first dose until 30 days after the last dose (or specified in the protocol).
2

Number of Participants With Dose-Limiting Toxicities (DLTs)

Time frame
From Cycle 1 Day 1 through Day 21. Each cycle is 21 days.

Secondary outcomes

1

D3S-001 maximum observed plasma concentration (Cmax)

Time frame
Up to 24 months.
2

D3S-001 time to maximum plasma concentration (tmax)

Time frame
Up to 24 months.
3

D3S-001 half-life (t1/2)

Time frame
Up to 24 months.
4

D3S-001 area under the concentration-time curve (AUC)

Time frame
Up to 24 months.

Other outcomes

Sponsors and contacts

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

D3 Bio (Wuxi) Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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