Various Clinical Trials in Oncology Announce Key Trial Milestones

Several oncology companies announced key trial milestones this week across the landscape of both blood cancers and solid tumors.

Notably, SynOx Therapeutics completed enrollment in its global phase 3 TANGENT study of emactuzumab for tenosynovial giant cell tumors, with results expected in 2026, while ALX Oncology also launched a phase 1 trial of ALX2004, an antibody-drug conjugate targeting EGFR-expressing solid tumors.

These developments highlight ongoing efforts to expand treatment options across rare tumors, blood cancers, lung cancer, solid tumors, and myeloid disorders, all of which are areas where significant unmet needs remain.

Phase 3 Tenosynovial Giant Cell Tumor Trial Completes Enrollment

Patient enrollment in TANGENT, a global phase 3 clinical trial of emactuzumab, has been completed for patients with tenosynovial giant cell tumors (TGCT), according to a news release from SynOx Therapeutics.

The TANGENT study is evaluating emactuzumab, an investigational monoclonal antibody that blocks CSF-1R, in patients with TGCT who cannot undergo or would not benefit from surgery. The trial enrolled patients across the United States, Canada, Europe and Asia, and top-line results are expected in early 2026. The primary goal of the study is to measure tumor response at six months, with additional outcomes focused on pain, stiffness, range of motion and quality of life. Patients will be followed for two years, and those whose tumors progress may receive open-label emactuzumab.

TGCT is a rare but aggressive joint disease that often affects the knee, hip or ankle. It can cause pain, swelling and limited mobility. Surgery is typically used to remove tumors, but more than half of patients with diffuse TGCT see their disease return within three years. In severe cases, untreated TGCT can lead to joint damage or the need for joint fusion or amputation.

GTB-3650 Expands Use in Phase 1 Trial for Blood Cancers

GT Biopharma has begun dosing in Cohort 3 of its phase 1 clinical trial of GTB-3650 for relapsed or refractory CD33-expressing blood cancers, following a safety review of earlier cohorts, the company announced in a news release.

GTB-3650 is a next-generation therapy built on the company’s TriKE natural killer (NK) cell engager platform. The trial is testing the treatment in patients whose disease has returned or has not responded to other therapies. Early data from the first two cohorts showed that GTB-3650 activated NK cells and spurred their expansion, with no safety or tolerability issues reported.

The ongoing trial will enroll up to approximately 14 patients across seven dose levels. Patients receive treatment in two-week cycles, with up to four months of therapy depending on clinical benefit. Researchers are assessing safety, immune activation, drug behavior in the body and signs of clinical activity.

Initial results from the study are expected later in 2025, according to the company.

First Patient Dosed with Ivonescimab in Phase 3 Trial for Limited-Stage SCLC

The first patient in a phase 3 clinical trial testing ivonescimab as a potential new treatment for people with limited-stage small cell lung cancer (LS-SCLC) has been dosed, according to a news release from Akeso.

The trial, called HARMONi-9, is evaluating ivonescimab, a first-in-class bispecific antibody that targets PD-1 and VEGF, as consolidation therapy for patients whose cancer has not progressed after standard chemoradiotherapy. Researchers aim to measure whether ivonescimab can help delay disease recurrence and improve survival in this aggressive form of lung cancer.

Small cell lung cancer accounts for approximately 15% of all lung cancers and is known to spread quickly. Currently, only one immunotherapy is approved for consolidation in LS-SCLC, leaving a significant unmet need. Ivonescimab aims to fill that need and has previously shown benefit in extensive-stage small cell lung cancer by prolonging progression-free survival.

With HARMONi-9 now underway, Akeso is expanding its effort to test the drug across earlier stages of lung cancer.

First Patient Dosed in Phase 1 Trial of ALX2004 for EGFR-Expressing Solid Tumors

ALX Oncology has begun a phase 1 clinical trial of ALX2004, a new antibody-drug conjugate designed to target EGFR-expressing solid tumors, according to a company news release. The first patient has now been treated. ALX2004 is built to overcome safety challenges seen with earlier EGFR-targeted therapies. In preclinical studies, the drug showed strong anti-tumor activity and a favorable safety profile, leading researchers to move it into human testing.

The trial will enroll patients with advanced or metastatic cancers, including non-small cell lung cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and colorectal cancer. The study will first test different dose levels, then expand to explore safety and early signs of effectiveness in larger groups of patients.

Initial safety results from the study are expected in the first half of 2026.

Global Phase 3 Study of Lisaftoclax for First-line Treatment MDS Cleared by U.S. FDA

The U.S. Food and Drug Administration and the European Medicines Agency have granted clearance to begin GLORA-4, a global phase 3 clinical trial testing lisaftoclax in combination with azacitidine for patients with newly diagnosed higher-risk myelodysplastic syndrome (MDS), according to a news release from Ascentage Pharma.

Lisaftoclax is a novel oral drug that targets Bcl-2, a protein that helps cancer cells survive. In earlier studies, lisaftoclax combined with azacitidine showed beneficial response rates and a manageable safety profile, suggesting it could improve outcomes for patients facing higher-risk MDS, a disease with few effective first-line options. Because current standard therapies for MDS only benefit about one-third of patients, there is a significant unmet need.

The GLORA-4 study is enrolling patients across the U.S., Europe and China. If successful, lisaftoclax could become the first Bcl-2 inhibitor approved for higher-risk MDS and the first new targeted therapy for this condition in more than 20 years.

References

1. “SynOx Therapeutics Completes Enrollment in Registrational Phase 3 TANGENT Clinical Trial Significantly Ahead of Timeline,” by SynOx Therapeutics Limited. News release; Aug. 5, 2025.
2. "GT Biopharma Advances into Cohort 3 of GTB-3650 Phase 1 Trial Following Safety Review of Cohort 2, by GT Biopharma, Inc. News release; Aug. 11, 2025.
3. "Akeso Announces First Patient Dosed in Phase III Trial of Ivonescimab as Consolidation Therapy for Limited-Stage SCLC After Definitive Radiotherapy," by Akeso, Inc. News release; Aug. 10, 2025.
4. “ALX Oncology Doses First Patient in Phase 1 Dose Escalation Trial Evaluating ADC ALX2004 for the Treatment of EGFR-Expressing Solid Tumors,” by ALX Oncology. News release; Aug. 19, 2025.
5. “Ascentage Pharma Announces Global Registrational Phase III Study of Lisaftoclax for First-line Treatment of Patients with Higher-Risk Myelodysplastic Syndrome Cleared by US FDA and EMA,” by Ascentage Pharma Group International. News release; Aug. 17, 2025.

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