Clinical trial · Interventional
Second-line CM082 Combined With Paclitaxel For Patients With Advanced Gastric Cancer
Safety and Preliminary Efficacy of CM082 in Combination With Paclitaxel for Treating Advanced Gastric Cancer Who Progressed on Standard First-line Treatment: a Phase 1, Dose-escalation Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, Phase 1b study which will be conducted in two parts: part A is the dose escalation study while part B is dose expansion study. The purpose of the dose escalation part is to identify the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CM082 combined with paclitaxel in patients with advanced gastric cancer who did not respond to first-line standard chemotherapy. In the subsequent dose expansion part, additional subjects will be enrolled to further explore the safety and preliminary clinical activity of CM082 and paclitaxel.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CM082 plus paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CM082 plus paclitaxel
- description
- In dose-escalation part, patients will be treated in dose levels at the following daily doses of CM082 and paclitaxel to establish the MTD and RP2D: CM082 100mg qd + paclitaxel 80mg/m2/day; CM082 150mg qd + paclitaxel 80mg/m2/day; CM082 200mg qd + paclitaxel 80mg/m2/day; In dose-expansion part, patients will be treated at the RP2D established in dose escalation part.
- interventionNames
- Drug: CM082 plus paclitaxel
Primary outcomes (2)
- measure
- DLT and MTD
- timeFrame
- 4 weeks
- description
- DLTs were defined as grade 4 hematological toxicity; grade 3 or more severe nonhematologic toxicity including nausea/vomit, constipation , Hypertension , not controlled by adequate supportive treatment (with exceptions of alopecia); grade 3 febrile neutropenia. The MTD was defined as the highest dose at which no DLT was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Fully understand the study and sign the informed consent voluntarily; * Patients with local advanced and/or metastatic gastric adenocarcinoma and/or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology; * Progressed on previous first-line standard chemotherapy; * Male or female with an age of 18-70 years(inclusive); * Body weight ≥40 kg (inclusive); * At least one measurable lesion (according to RECIST1.1); * Performance status score (ECOG score) 0-1; * Expected survival \>12 weeks; * Adequate bonemarrow, liver, renal and cardiac function, based on blood tests, electrocardiograms, and cardiac echocardiograms. Exclusion Criteria: * Participating in another drug clinical trial in the past 4 weeks; history of systemic anti-tumor treatment within 4 weeks prior to administration of the study drug; history of any major surgery within 4 weeks prior to enrollment to the study; * Who have not recovered from toxicity caused by previous anti-cancer treatment (CTCAE\>grade 1), or not completely recovered from previous surgery; * Having received previous chemotherapy regimens with taxanes; * Take medications that may extend QTc and/or Tdp; * Active brain metastasis or meningeal metastasis; * Uncontrolled hypertension (BP\>150/90 on medications); * Other malignancies within the last 5 years, except for adequately treated cervix carcinoma in situ or basal or squamous-cell or basal cell carcinoma; * QT interval \> 450 ms; * Uncontrolled clinical active infection, e.g. acute pneumonia, active hepatitis B or hepatitis C; HIV positive; syphilitic spiral antibody positive; * Dysphagia, intractable vomiting or known drug malabsorption; * Drug or alcohol abuser.
References
Publications (0)
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