HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer (NCT05728619) | Clinical Trial Compass
UnknownPhase 1/2
HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer
China64 participantsStarted 2023-02-03
Plain-language summary
The Phase 1b part of this clinical trial is to investigate the safety and pharmacokinetic (PK) characteristics of HTMC0435 tablets combined with temozolomide in patients with various advanced solid tumors (recurrent small cell lung cancer is preferred). The Phase 2 part of the study is a multi-center, open-label, single-arm trial to investigate the preliminary efficacy of HTMC0435 and temozolomide in patients with recurrent small cell lung cancer (SCLC) at the recommended phase 2 dose.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female, age ≥18 and \<75 years old
✓. Patients with histologically or cytologically confirmed recurrent or progressive extensive-stage SCLC, who have previously received at least first-line and no more than second-line treatments (HRR mutations are preferred)
✓. \[Only applicable to phase II part\] At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1
✓. Expected survival period ≥3 months
✓. Prior to the enrollment, no serious hematopoietic abnormality, and generally normal function of heart, lung, liver and kidney
✓. Understand and sign the informed consent form (ICF) voluntarily. Be willing and able to complete routine visits, treatment plans, laboratory examinations and other procedures.
Exclusion criteria
✕. Prior treatment with any poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP) inhibitor
✕. Prior temozolomide treatment interruption caused by toxicity
✕. Received treatment with chemotherapy, radiation, biotherapy, endocrine therapy, immunotherapy, or other anti-tumor therapy ≤4 weeks prior to the first dose of HTMC0435
✕. Any unrecovered AE of prior therapy ≥CTCAE 5.0 Grade 1 (except for toxicity that the investigators judged to have no safety risks, such as alopecia)
What they're measuring
1
Dose-limiting toxicities (DLT) of HTMC0435 combined with Temozolomide
Timeframe: Cycle 1 Day 1 to Cycle 1 Day 21
2
Adverse events (AE) of HTMC0435 combined with Temozolomide
Timeframe: Through study completion, an average of 6 months
3
Maximum tolerable dose (MTD) and RP2D of HTMC0435 combined with Temozolomide
Timeframe: Through study completion, an average of 6 months
Trial details
NCT IDNCT05728619
SponsorShanghai Yidian Pharmaceutical Technology Development Co., Ltd.
✕. Currently suffering from interstitial lung disease ≥CTCAE Grade 2
✕. Major surgery (excluding needle biopsy) within 4 weeks before the first dose of HTMC0435
✕. Past surgical history or severe gastrointestinal diseases that the investigator believes may affect the absorption, distribution or metabolism of the study drug, such as dysphagia, active gastric ulcer, ulcerative colitis, Crohn's disease, ileus, etc.
✕. History of severe cardiovascular and cerebrovascular diseases