Combination of HLX208 and Trametinib for Advanced Solid Tumors
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
This study is testing a new combination of two drugs, HLX208 and trametinib, to see if it can help people with advanced solid tumors that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Henlius Biotech Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation, trametinib |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT04965220 on ClinicalTrials.gov |
What this trial studies
This phase I clinical trial evaluates the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208, a BRAF V600E inhibitor, in combination with trametinib for patients with advanced solid tumors. The study aims to enroll patients who have metastatic or recurrent BRAF-positive solid tumors that have not responded to standard treatments. Participants will be monitored for their response to the treatment and any side effects experienced during the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced BRAF-positive solid tumors that have failed standard treatments.
Not a fit: Patients who have previously been treated with BRAF or MEK inhibitors or those with symptomatic brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that harbor BRAF V600E mutations.
How similar studies have performed: Other studies have shown promising results with BRAF inhibitors in similar patient populations, indicating potential for success with this combination approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou
- Sun Yat-sen University Cancer Center — Guangzhou, China (Recruiting)
Study contacts
- Study coordinator: Zhang Li, leading PI
- Email: zhangli@sysucc.org.cn
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.