A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- HLX 208
- Conditions
- Solid Tumor
- Sponsor
- Shanghai Henlius Biotech
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- MTD
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors
Investigators
Eligibility Criteria
Inclusion Criteria
- •18Y≤Age≤75Y
- •Good Organ Function
- •Expected survival time ≥ 3 months
- •Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment
- •Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
- •ECOG score 0-1;
- •Expected survival time of more than 3 months;
Exclusion Criteria
- •Previous treatment with BRAF inhibitors or MEK inhibitors
- •Symptomatic brain or meningeal metastases (unless the patient has been on \> treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- •Current or former patients with interstitial lung disease;
- •Active clinical severe infection;
- •A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- •Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
Arms & Interventions
ATC
HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
Intervention: HLX 208
Primary brain tumor
HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
Intervention: HLX 208
CRC(KRAS mutant)
HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
Intervention: HLX 208
other solid tumor
HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)
Intervention: HLX 208
Outcomes
Primary Outcomes
MTD
Time Frame: from first dose to the end of Cycle 1 (each cycle is 21 days)
maximum tolerated dose
Secondary Outcomes
- RP2D(from first dose to the end of Cycle 1 (each cycle is 21 days))
- Peak Plasma Concentration (Cmax) of HLX208(from first dose to the beginning of Cycle 4 (each cycle is 21 days))
- ORR(from first dose to the last patient was followed up for 6 month)
- Area under the plasma concentration versus time curve (AUC)of HLX208(from first dose to the beginning of Cycle 4 (each cycle is 21 days))