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Retinol palmitate

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In US studies, dose escalation started at a 25 mg BID dose and subsequent dose-escalation groups included: 50 mg BID, 100 mg BID, 150 mg BID, 225 mg BID and 325 mg BID. In this study, the actual dose escalation will be based on a priming dose one level below the highest safe dose or two levels below the MTD that has been tested in US clinical trials when the enrolment of the China study actually initiates, and subsequent escalated doses may be adjusted as appropriate (e.g., the escalated doses following 150 mg BID in the China study may be adjusted to 200 mg BID, 250 mg BID and 300 mg BID. The actual priming dose and subsequent escalated doses for the China study are determined by the SMC) The dose expansion stage in this study will be initiated at the MTD or the optimal dose determined by the SMC as a fixed dose level (MTD or the optimal dose needs to be reviewed by the SMC and subjects are safe and tolerable at that dose level).

Dose escalation starting dose will be based on a priming dose one level below the highest safe dose or two levels below the MTD that has been tested in US clinical trials.

Dose expansion will be initiated at the MTD or the optimal dose determined by the SMC as a fixed dose level.

ABM-1310

Priscilla Lee

Jian Fang

Xuejun Yang

Aimin Zang

Yanqiao Zhang

Rutong Yu

Jinhua Wen

Yong Li

Ying Chen

Yuping Sun

Junye Wang

Hua Zhong

Tianshu Liu

Xiaohua Liang

Jin Li

Caicun Zhou

Xia Song

You Lu

Ying Yuan

Jin Li, M.D.

This is a Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in patients with BRAF V600-Mutant advanced solid tumors. This study consists of two stages: dose escalation and dose expansion. During the dose escalation stage, a classic "3+3" design will be used to guide dose escalation to determine MTD and RP2D. The dose expansion stage will be initiated at the MTD or the optimal dose determined by the Safety Monitoring Committee (SMC ) as a fixed dose level (MTD or the optimal dose needs to be reviewed by the SMC and subjects are safe and tolerable at that dose level).

This is a Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in patients with BRAF V600-Mutant advanced solid tumors. The primary objective of this study is to evaluate the safety and tolerability of ABM-1310 monotherapy, and to determine MTD and RP2D. The study will be conducted in two stages:

Dose escalation stage: The dose escalation will be guided by a "3+3" design. In this study, the actual dose escalation will be based on a priming dose one level below the highest safe dose or two levels below the MTD that has been tested in US clinical trials when the enrolment of the China study actually initiates, and subsequent escalated doses may be adjusted as appropriate (e.g., the escalated doses following 150 mg BID in the China study may be adjusted to 200 mg BID, 250 mg BID and 300 mg BID. The actual priming dose and subsequent escalated doses for the China study are determined by the SMC).

Dose expansion stage: Subjects will begin to receive oral doses of ABM-1310, BID, for 28-day cycles at a fixed dose level (as determined at the dose escalation stage).The dose expansion stage is expected to include the following two cohorts of advanced solid tumors with BRAF V600 mutations:

Cohort 1: primary extracranial solid tumors, subjects with BMs preferentially enrolled, up to 15 patients per tumor type; Cohort 2: primary intracranial solid tumors, N = up to 30 patients.

The study will be conducted in two stages:

Dose escalation stage: To determine MTD/RP2D and evaluate the safety and tolerability of ABM-1310 monotherapy.

Dose expansion stage: To further determine RP2D and evaluate the preliminary efficacy of ABM-1310 monotherapy.

A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors

A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Cancer Activity of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors

MTD is defined as the highest dose level at which DLT is observed in ≤ 1/6 subjects at one single dose group

RP2D will be a dose either below or equal to MTD

DLT will be evaluated according to NCI-CTCAE V5.0 criteria

Safety and tolerability of ABM-1310 monotherapy

Pharmacokinetic (PK) profile of ABM-1310 monotherapy

Preliminary efficacy of ABM-1310 monotherapy

Preliminary intracranial efficacy of ABM-1310 monotherapy

Spots Global Cancer Trial Database for intracranial solid tumor