Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation

ConditionSolid Tumors (Phase 1)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years#Male and female patients, at time of signing informed consent form (ICF).

ECOG performance status 0-1, or KPS (Karnofsky Performance Status) Score≥70.

Life expectancy ≥ 3 months.

Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology, who have failed standard treatment (disease progression after treatment or intolerable treatment); patients who have previously received BRAF and/or MEK inhibitor therapy are allowed to be included in this study.

Disqualifiers

malignant tumor within 2 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.

Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.

Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia, dermal toxicity, and other toxicity considering no safety risks by investigator.

Any disease which would preclude drug absorption, metabolism or pharmacokinetics, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.

Trial design

Design model

Single group

Treatments tested in this trial

HSK42360-Na
Drug
Oral administration

Treatment groups

159 Participants

are divided into 2 treatment groups

Group A: Phase Ia: HSK42360-Na as monotherapyExperimental treatment 1 intervention

Group B: Phase Ib: HSK42360-Na as monotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

MTD

MTD determination: dose limiting toxicity (DLT) rate

Time frame

Up to approximately 52 months

DLTs

Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1

Time frame

Up to approximately 52 months

AEs

Rate and severity of adverse events of HSK42360-Na as monotherapy

Time frame

Up to approximately 52 months

RP2D

The RP2D is determined based on multiple parameters

Time frame

Up to approximately 52 months

Secondary outcomes

Overall response rate (ORR)

ORR, defined as the proportion of patients who experience a best response of confirmed CR or PR according to RECIST 1.1/RANO

Time frame

Up to approximately 52 months

Disease control rate (DCR)

DCR, defined as the proportion of patients who experience a best response of CR, PR, or stable disease (SD) according to RECIST 1.1

Time frame

Up to approximately 52 months

Duration of response (DOR)

DOR, defined as the time from first documented response of complete response (CR) or partial response (PR) to the date of first documented progressive disease or death due to any cause, whichever occurs first

Time frame

Up to approximately 52 months

Progression free survival (PFS)

PFS, defined as the time frocease or death due to any cause, whichever occurs first

Time frame

Up to approximately 52 months

Other outcomes

circulating tumor DNA (ctDNA)

Assess treatment-induced modulation of MAPK pathway biomarkers

Time frame

Up to approximately 52 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haisco Pharmaceutical Group Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

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