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A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer.

ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou DAC Biotechnology Co., Ltd.

About this trial

This is a Phase Ib/II, open-label clinical study designed to evaluate the safety, tolerability, preliminary anti-tumor activity, recommended Phase 2 dose (RP2D), pharmacokinetic (PK) characteristics, and immunogenicity of DXC006 in combination with an immune checkpoint inhibitor (ICI) or platinum-based chemotherapy in patients with small cell lung cancer (SCLC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily signed informed consent and willingness to comply with the protocol requirements.

Male or female.

Age ≥18 years and ≤75 years.

Life expectancy ≥3 months.

Disqualifiers

Histologically or cytologically confirmed combined SCLC, NSCLC, sarcomatoid carcinoma, or large cell neuroendocrine carcinoma.

Within 14 days prior to the first dose: underwent plasmapheresis; received systemic corticosteroid therapy at a daily dose >10 mg prednisone or equivalent (or equivalent anti-inflammatory activity) for more than 3 consecutive days (short-term use for prevention of contrast media allergy is permitted).

Prior allogeneic hematopoietic stem cell transplantation (HSCT) or history of solid organ transplantation.

Prior treatment with CD56-targeted therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DXC006

    Drug

    Participants receive DXC006 intravenously on Day 1 every 3 weeks.

  • Toripalimab

    Drug

    Participants receive Toripalimab intravenously on Day 1 every 3 weeks.

  • Carboplatin

    Drug

    Participants receive Carboplatin intravenously on Day 1 every 3 weeks (up to 6 cycles).

  • Cisplatin

    Drug

    Participants receive Cisplatin intravenously on Day 1 every 3 weeks (up to 6 cycles).

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: DXC006 + ICIExperimental treatment 2 interventions
Group B: DXC006 + Platinum(Carboplatin )Experimental treatment 2 interventions
Group C: DXC006 + Platinum(Cisplatin )Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.
2

6-month progression-free survival rate

Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
3

Recommended Phase 2 Dose (RP2D)

Time frame
Final RP2D confirmation upon completion of the Phase Ib (up to 12 months).
4

Measurement of objective response rate (ORR) per RECIST 1.1

Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 year.

Secondary outcomes

1

Maximum observed serum or plasma concentration (Cmax)

Time frame
Through study completion an average of 1 year.
2

Maximum serum drug time（Tmax）

Time frame
Through study completion an average of 1 year.
3

Apparent volume of distribution(Vd)

Time frame
Through study completion an average of 1 year.
4

Volume of distribution at steady state (Vss)

Time frame
Through study completion an average of 1 year.

Other outcomes

Sponsors and contacts

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

Hangzhou DAC Biotechnology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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