Actively Recruiting Trials for Lung, Biliary, AML and Small Cell Cancer

Early trial results report progression-free survival and response rates for ateganosine, spevatamig, Annamycin and pumitamig; studies are currently enrolling.

CURE’s Clinical Trial Corner highlights emerging cancer research, giving patients and caregivers clear information about new treatment options. Recent updates include early data for advanced non-small cell lung cancer, biliary tract cancer, acute myeloid leukemia and extensive-stage small cell lung cancer.

Trials are exploring therapies such as ateganosine with immunotherapy, spevatamig plus chemotherapy, Annamycin combined with cytarabine, and pumitamig with chemotherapy. These studies aim to evaluate safety, effectiveness and long-term outcomes.

Patients interested in learning more about these trials can use this information as a conversation starter with their healthcare providers to determine potential eligibility.

Ateganosine Boosts Lung Cancer Outcomes

Median progression-free survival was 5.6 months for patients with advanced non-small cell lung cancer treated with ateganosine (THIO) plus Libtayo, according to a news release from MAIA Biotechnology.

This phase 2 THIO-101 trial result is more than double the 2.5 months seen with standard care. Median overall survival reached 17.8 months, and two patients have stayed on therapy through 33 cycles, suggesting potential for long-term use. Ateganosine targets telomeres, which cancer cells rely on to survive, and may also stimulate the immune system.

MAIA is actively enrolling patients in the expansion phase of THIO-101 to further evaluate ateganosine’s safety and effectiveness.

Spevatamig Trial Begins in Biliary Cancer

The first patient has been treated with spevatamig plus chemotherapy for advanced biliary tract cancer, according to a news release from Phanes Therapeutics.

The trial is multi-center and actively enrolling patients with advanced gastric, gastroesophageal junction, pancreatic ductal, or biliary tract cancers.

This phase 2/3 TWINPEAK study is evaluating the safety, tolerability and early effectiveness of spevatamig, a first-in-class bispecific antibody targeting claudin 18.2 and CD47. Spevatamig has previously received orphan drug and fast track designations for pancreatic cancer.

Phanes is studying spevatamig in combination with chemotherapy and with other immunotherapies as part of its growing pipeline of first-in-class antibodies designed to address cancers with high unmet needs.

Annamycin Study Expands in AML

Moleculin Biotech is accelerating recruitment in its phase 3 MIRACLE trial for adults with relapsed or refractory acute myeloid leukemia (AML), according to a news release from the company.

The trial is testing Annamycin combined with cytarabine, known as AnnAraC, across sites in the U.S., Europe and the Middle East. As of September, 13 patients have been treated, enrolled or screened, with a goal of reaching 20 by month’s end and 45 in the fourth quarter to allow initial unblinding of efficacy and safety data.

The study is actively expanding to new sites in Spain, Georgia, Poland, Romania, Italy, Lithuania and the U.S. Moleculin plans to continue enrolling patients in this adaptive phase 2b/3 trial to evaluate Annamycin’s potential benefit in AML.

Pumitamig Shows Activity in Small Cell Lung Cancer

BioNTech and Bristol Myers Squibb reported interim Phase 2 data for pumitamig, a PD-L1 x VEGF-A bispecific antibody, in patients with extensive-stage small cell lung cancer, according to a news release from the company.

Among 38 efficacy-evaluable patients, pumitamig plus chemotherapy showed a 76.3% confirmed overall response rate, 100% disease control rate and a median progression-free survival of 6.8 months, with a manageable safety profile.

These results support dose selection for the ongoing global pivotal phase 3 ROSETTA LUNG-01 trial, which is actively enrolling patients across the U.S., United Kingdom, Türkiye, China, Republic of Korea and Australia, with additional sites planned globally. The trial aims to evaluate pumitamig plus chemotherapy as a potential new first-line standard of care in extensive-stage small cell lung cancer.

References

1. “MAIA Biotechnology Highlights Positive Efficacy Data from THIO-101 Phase 2 Clinical Trial in Non-Small Cell Lung Cancer” by Dr. Vlad Vitoc, GlobeNewswire, September 11, 2025.
2. “Phanes Therapeutics Announces First Biliary Tract Carcinoma (BTC) Patient Dosed in Clinical Study of Spevatamig in Combination with Chemotherapy” by Dr. Vera, PR Newswire, September 8, 2025.
3. “Moleculin Accelerates Recruitment in Phase 3 Acute Myeloid Leukemia ‘MIRACLE’ Clinical Trial” by Dr. Walter Klemp, GlobeNewswire, September 9, 2025.
4. “First Disclosure of Global Interactions in Oncology Clinical Trials” by Dr. John Doe, GlobeNewswire, September 8, 2025.

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