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

NCT07559929 | Not Yet Recruiting Phase 1

• 1 other identifier: DXC006-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (6)

• Progression Free Survival (PFS)

  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.

• 6-month progression-free survival rate

  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.

• Recommended Phase 2 Dose (RP2D)

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

• Measurement of objective response rate (ORR) per RECIST 1.1

  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.

• Measurement of disease control rate (DCR)

  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.

• Incidence of Adverse Events (AEs)

  After first infusion of study drug, through study completion an average of 2 year.

Secondary Outcomes (12)

• Maximum observed serum or plasma concentration (Cmax)

  Through study completion an average of 1 year.

• Maximum serum drug time（Tmax）

  Through study completion an average of 1 year.

• Apparent volume of distribution(Vd)

  Through study completion an average of 1 year.

• Volume of distribution at steady state (Vss)

  Through study completion an average of 1 year.

• Terminal phase elimination half life (t½)

  Through study completion an average of 1 year.

Study Arms (3)

DXC006 + ICI

EXPERIMENTAL

Drug: DXC006; Drug: Toripalimab

DXC006 + Platinum(Carboplatin )

EXPERIMENTAL

Drug: DXC006; Drug: Carboplatin

DXC006 + Platinum(Cisplatin )

EXPERIMENTAL

Drug: DXC006; Drug: Cisplatin

Interventions

DXC006 DRUG

Participants receive DXC006 intravenously on Day 1 every 3 weeks.

DXC006 + ICI; DXC006 + Platinum(Carboplatin ); DXC006 + Platinum(Cisplatin )

Toripalimab DRUG

Participants receive Toripalimab intravenously on Day 1 every 3 weeks.

DXC006 + ICI

Cisplatin DRUG

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

DXC006 + Platinum(Cisplatin )

Carboplatin DRUG

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

DXC006 + Platinum(Carboplatin )

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
• Histologically or cytologically confirmed small cell lung cancer (SCLC).
• Toxicity from prior anti-tumor therapy has resolved to ≤ Grade 1 as defined by NCI-CTCAE version 6.0 (except alopecia); peripheral neuropathy must have completely resolved.
• Adequate hepatic, renal, coagulation, and cardiac function.
• The participant and their spouse agree to use effective barrier or pharmacologic contraception (excluding rhythm method) from the time of signing the informed consent until 6 months after the last dose of study treatment.

You may not qualify if:

• 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.
• Symptomatic brain metastases or leptomeningeal metastases.
• History of severe or life-threatening immune-related adverse events or infusion-related reactions (including permanent discontinuation of immuno-oncology therapy due to intolerance).
• Active autoimmune disease or immunodeficiency, or a history of such conditions.
• Evidence of significant cardiovascular risk.
• Dyspnea or current requirement for continuous supplemental oxygen therapy, or current active pneumonitis or interstitial lung disease (except mild cases as determined by the investigator).
• History of other primary malignancies, with the exception of malignancies that have been cured and have a very low risk of recurrence within 5 years, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast.
• Severe non-healing wound, ulcer, or bone fracture; or major surgery within 28 days prior to dosing, or anticipated major surgery during the study period.
• History of hypersensitivity to any component or excipient of DXC006, immune checkpoint inhibitors, or platinum-based chemotherapy.
• Active hepatitis B (HBV-DNA above the upper limit of normal at the central laboratory or \>1000 copies/mL); hepatitis C infection (positive hepatitis C antibody or positive HCV RNA PCR result).
• Known positive serology for human immunodeficiency virus (HIV); active syphilis (patients with positive syphilis antibody only are eligible); potential active pulmonary tuberculosis (chest imaging within 3 months prior to the first dose suggestive of active tuberculosis infection).
• Active bleeding within 30 days prior to screening, or risk of major gastrointestinal bleeding or hemoptysis as determined by the investigator; or hereditary bleeding tendency, coagulopathy, or bleeding symptoms requiring other medical intervention.

Sponsors & Collaborators

• Hangzhou DAC Biotechnology Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

toripalimab; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

Li Zhang, Doctoral degree

CONTACT

+86-020-87343565; zhangli@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 30, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)