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APG-2449

Phase 1

Advanced Solid Cancer | Small molecule | Oncology |Ascentage Pharma Group International - American Depository Shares|Last Updated: Jul 23, 2026

Target and mechanism

Molecular targetFAK/ALK/ROS1
Target classTyrosine Kinase
ModalitySmall molecule

Also known as APG -2449

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment165

FDA Designations

No designations recorded

Clinical trial landscape

APG-2449 · 1 trial · 5 indications

Phase 1 1
NCT03917043APG-2449 in Patients With Advanced Solid TumorsAdvanced Solid Cancer
RECRUITING165 Analytics
PHASE1RECRUITING
APG-2449 in Patients With Advanced Solid Tumors
Advanced Solid CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum Tolerated Dose (MTD)
28 days

To determine the maximum tolerated dose (MTD) of APG-2449 in subjects with advanced solid tumors

Recommended Phase 2 dose (RP2D)
28 days

To determine the tentative recommended Phase 2 dose (RP2D) of APG-2449 in subjects with advanced solid tumors

Secondary Endpoints

Maximum plasma concentration (Cmax)
28 days
Area under the plasma concentration versus time curve (AUC)
28 days
Phosphorylation of FAK protein
28 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
APG-2449EXPERIMENTALAPG-2449 will be explored sequentially using a standard 3+3 escalation scheme at the dose escalation phase and up to 30-40 patient at the MTD/RP2D dose level.

Interventions

NameTypeDescription
APG-2449DRUGCapsule, multiple dose cohorts, oral administration every day (QD) of a 28-day cycle
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Dose exploration stage: non-small cell lung cancer diagnosed by histology and/or cytology and positive for ALK/ROS1 gene fusion (molecular diagnosis confirmed by the investigator) and malignant pleural mesothelioma, esophageal cancer and ovarian cancer. Kind of patients with ...

Countries:China
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Recent Changes (Last 90 Days)

MEDIUMAug 1, 2026NCT03917043primaryCompletionDate: changed
MEDIUMAug 1, 2026NCT03917043primaryCompletionDate: changed
MEDIUMAug 1, 2026NCT03917043primaryCompletionDate: changed
LOWMay 24, 2026NCT03917043studyFirstPostDate: changed

Frequently asked questions about APG-2449

What is APG-2449 used for?

APG-2449 is an investigational small molecule being studied for the treatment of platinum-resistant recurrent ovarian cancer and advanced solid cancers, including non-small cell lung cancer, esophageal cancer, and malignant pleural mesothelioma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does APG-2449 target?

APG-2449 targets FAK, ALK, and ROS1, which are tyrosine kinases involved in tumor growth and progression. By inhibiting these targets, the drug aims to interfere with cancer cell signaling pathways. This mechanism is being evaluated in early-stage clinical trials for solid tumors.

Who makes APG-2449?

APG-2449 is being developed by Ascentage Pharma Group International, a biopharmaceutical company listed on the stock exchange under the ticker AAPG. The company is conducting clinical trials for this investigational drug in China.

What phase is APG-2449 in?

APG-2449 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing trials are designed to evaluate its safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.

What clinical trials is APG-2449 in?

APG-2449 is being studied in two Phase 1 clinical trials. The first, NCT03917043, evaluates APG-2449 in patients with advanced solid tumors. The second, NCT06687070, studies APG-2449 alone or in combination with PLD in patients with platinum-resistant recurrent ovarian cancer or advanced solid tumors. Both trials are recruiting participants in China.

Is APG-2449 the same as APG-2449?

Yes, APG-2449 is also known as APG-2449. The drug is referred to by this name in clinical trial registries and scientific literature. No other alternative names have been reported for this investigational agent.