Ascentage nearly doubles enrollment in APG-2449 ovarian cancer trial
The Phase 1 dose-finding study of the ALK/ROS1/FAK inhibitor grew its target to 90 patients and pushed its primary completion date out a year, tracking normally for an early-stage safety readout.
Executive Summary
- Ascentage Pharma Group Inc. widened the target enrollment of its Phase 1 trial of APG-2449 in platinum-resistant ovarian cancer and pushed the primary completion date out by a year, a routine adjustment for a dose-finding study still recruiting.
- The trial is a dose-finding and tolerability study, not an efficacy readout: its primary endpoints are dose-limiting toxicity and treatment-related adverse events, so the larger cohort mainly deepens the safety picture for the combination with PLD, a chemotherapy agent.
- APG-2449 sits without a direct peer combining ALK, ROS1 and FAK inhibition in ovarian cancer, while single-target ALK inhibitors already approved in ALK-positive lung cancer are being tested in ovarian and other tumor types through separate mechanisms.
- The trial's forward readout will be the first to show whether the FAK-inhibitor combination adds tolerability risk on top of the chemotherapy backbone, a question the expanded cohort is now positioned to answer with more patients.
The update
The trial, registered as NCT06687070, tests APG-2449 alone or combined with pegylated liposomal doxorubicin (PLD, a chemotherapy agent) in patients with platinum-resistant recurrent ovarian cancer or advanced tumors. The registry recorded the enrollment increase from 50 to 90 patients and a primary completion date shift from May 2026 to May 2027 on July 21, 2026. The trial began recruiting in December 2024 and remains open. NCT06687070+1APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced STNCT06687070APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced STJul 21, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The endpoint bar
The trial's registered primary endpoints are dose-limiting toxicity within the first 28 days of treatment and treatment-related adverse events graded per NCI-CTCAE version 5.0 over one year. Neither endpoint measures tumor response or survival; this is a Phase 1 study built to characterize how patients tolerate APG-2449, an oral small molecule that inhibits ALK, ROS1 and FAK, when given alone or layered onto PLD. The trial enrolls women with ovarian, fallopian tube or primary peritoneal carcinoma who have already failed platinum-based therapy, a population with few targeted options. NCT06687070APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced STNCT06687070
Reading the enrollment move
The operational risk model classifies this enrollment change as typical for the trial's design, sitting inside the routine band the model uses to flag Phase 1 protocol updates, and the trial's registry-churn profile shows two amendment events in roughly a year and a half, a moderate but unremarkable pace. The one-year push in the primary completion date accompanies the larger cohort rather than standing alone, consistent with a sponsor adding capacity to the same dose-finding and combination-testing design rather than signaling a stalled program. APG-2449APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resistant Recurrent OC or Advanced STJul 21, 2026
The competitive frame
No other industry trial pairs an ALK/ROS1/FAK inhibitor with ovarian cancer at this stage: only one other trial anywhere targets ALK in ovarian cancer, Ascentage's own earlier-stage APG-2449 study in broader tumor types. The nearest mechanism-sharing comparator in clinical testing is InxMed (Shanghai) Co., Ltd.'s ifebemtinib, an ALK-targeted small molecule tested in non-small cell lung cancer rather than ovarian cancer. Single-target ALK inhibitors including Pfizer's lorlatinib and crizotinib, Novartis's ceritinib and Hoffmann-La Roche's entrectinib are approved for ALK-positive non-small cell lung cancer, not ovarian cancer, so they stand as regulatory precedent for the target class rather than as approved options in this indication. Ovarian cancer trials targeting ALK show no completions or terminations on record, leaving no track record yet to benchmark against.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.