HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors

Henlius Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Drug: HLX 208

Study type: Interventional

Funder types: Industry

Identifiers

NCT04965220

HLX208-MEK-001

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 4 patient groups

ATC

Experimental group

Description:

HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)

Treatment:

Drug: HLX 208

Primary brain tumor

Experimental group

Description:

HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)

Treatment:

Drug: HLX 208

CRC(KRAS mutant)

Experimental group

Description:

HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)

Treatment:

Drug: HLX 208

other solid tumor

Experimental group

Description:

HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first)

Treatment:

Drug: HLX 208