New Trials Advance Treatments for Lymphoma, Lung Cancer and Sarcomas

July 25, 2025
Spencer Feldman
Spencer Feldman

Spencer, Assistant Editor of CURE®, has been with MJH Life Sciences since 2024. A graduate of Rowan University with a bachelor's degree in health communication, Spencer enjoys spending time with family and friends, hiking, playing guitar and rock climbing.

New clinical trials are advancing treatments for cutaneous T-cell lymphoma, advanced solid tumors, pediatric sarcomas and ALK-positive lung cancer.

Recent progress in cancer research is driving new treatment options for people with cutaneous T-cell lymphoma, advanced solid tumors, pediatric sarcomas and ALK-positive lung cancer. Several clinical trials have reached important milestones, including new site activations, first patient dosing and completion of early-phase studies.

VCU Massey First U.S. Site in Global Phase 2a Trial of PTX-100 for Cutaneous T-Cell Lymphoma

VCU Massey Comprehensive Cancer Center is the first site in the United States to be activated in a global phase 2a trial evaluating PTX-100 (also known as GGTI-2418) for the treatment of cutaneous T-cell lymphoma, a rare and often treatment-resistant form of T-cell lymphoma, according to a news release from the cancer center.

PTX-100 is a first-in-class small molecule that blocks geranylgeranyl transferase-1, an enzyme involved in cancer cell survival.

The global phase 2a trial is enrolling people with relapsed or treatment-resistant cutaneous T-cell lymphoma to further assess the safety and effectiveness of PTX-100. It is taking place at leading academic cancer centers in the United States, Australia and Europe.

For more information about the study or to inquire about eligibility, patients and referring physicians can contact Massey’s Clinical Trials Office or submit a clinical trial request form.

First Patient Dosed in Phase 2 of BIPAVE-001 Trial for Advanced Solid Tumors

The first patient has been dosed in the phase 2 portion of the phase 1/2 BIPAVE-001 trial evaluating AI-081, a potential best-in-class PD-1 and VEGF bispecific antibody.

The BIPAVE-001 phase 1/2 trial is evaluating the safety and effectiveness of AI-081, along with how the body processes the drug, in two parts. Part A is an ongoing first-in-human phase 1 study testing different doses in patients with advanced solid tumors. Part B is the phase 2 portion, focusing on finding the best dose by evaluating AI-081 either alone or combined with standard treatments, depending on cancer type. The study is underway at 11 sites across the United States and has also been approved by China’s regulatory agency.

AI-081 is a bispecific antibody that targets PD-1 and VEGF for advanced solid tumors. It combines two high-affinity antibodies in a proven design to boost immune response. Preclinical studies showed AI-081 binds both targets strongly and works better than similar drugs by enhancing PD-1 blockade while blocking VEGF. This dual action may improve treatment effectiveness.

To learn more about the trial, use the clinical trial ID NCT06635785 at clinicaltrials.gov, or visit www.oncoc4.com.

Actuate Completes Phase 1 Trial of Elraglusib Combos for Pediatric Cancer

Actuate Therapeutics announced the completion of the phase 1 portion of its clinical study evaluating elraglusib monotherapy or in combination with irinotecan, irinotecan plus temozolomide, or cyclophosphamide plus topotecan in pediatric patients with refractory malignancies.

Elraglusib inhibits glycogen synthase kinase-3 beta, a target involved in cancer progression. Early signs of activity, especially in treatment-resistant Ewing sarcoma, support advancing the program to a phase 2 study in children, adolescents and adults with relapsed or refractory disease.

The open-label Phase 1/2 trial enrolled 10 patients with relapsed or refractory Ewing sarcoma treated with elraglusib plus topotecan and cyclophosphamide. The study is ongoing at multiple centers.

For more information about the trial or to inquire about eligibility, use the clinical trial ID NCT04239092 at clinicaltrials.gov or contact Actuate Therapeutics.

ALKAZAR Phase 3 Trial Evaluating Neladalkib for Lung Cancer Subset

The first patient has been dosed in the phase 3 trial ALKAZAR, evaluating neladalkib for tyrosine kinase inhibitor (TKI)-naive patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer, versus Alecensa (alectinib), a front-line standard of care, according to a news release from Nuvalent.

Neladalkib is a brain-penetrant ALK inhibitor designed to work in patients whose lung cancer has stopped responding to earlier ALK-targeted treatments, as per the release. It may help control tumors with tough-to-treat mutations and brain metastases while avoiding certain side effects linked to other drugs.

The ALKAZAR trial is a global phase 3 randomized, controlled study. Around 450 patients who have not previously received a TKI will be enrolled and randomly assigned to receive either neladalkib or Alecensa. The primary endpoint is progression-free survival. Secondary endpoints include overall survival, progression-free survival by investigator assessment, time to intracranial response and intracranial objective response rate (assessed by blinded independent central review), intracranial duration of response, objective response rate, duration of response, time to intracranial progression and safety.

The trial is recruiting in St. Louis, Missouri and New Hyde Park, New York.

For more information about the trial or to inquire about eligibility, use the clinical trial ID NCT06765109 at clinicaltrials.gov.

References

  1. “Massey becomes first U.S. site to enroll patients in global phase 2a trial of first-in-class therapy for T-cell lymphoma.” VCU Massey Comprehensive Cancer Center, July 18, 2025.
  2. “OncoC4 doses first patient with potential best-in-class PD-1 VEGF bispecific antibody AI-081 in phase 2 portion of BIPAVE-001 trial for advanced solid tumors in US.” OncoC4, July 22, 2025.
  3. “Actuate Therapeutics advances clinical program in Ewing sarcoma after positive phase 1 trial demonstrates complete and partial responses in difficult-to-treat pediatric sarcomas.” Actuate Therapeutics, July 17, 2025.
  4. “Nuvalent announces initiation of ALKAZAR phase 3 randomized controlled trial evaluating neladalkib for patients with TKI-naive ALK-positive NSCLC.” Nuvalent, July 21, 2025.

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