TQB3909 tablets combined with azacitidine for myeloid malignancies

A Phase Ib/II Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of TQB3909 Tablets in Combination With Azacitidine in Subjects With Myeloid Malignancies

This trial tests whether taking oral TQB3909 together with azacitidine helps adults with myeloid malignancies respond better to treatment and tolerate therapy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 138 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 21 sites (Bengbu, Anhui and 20 other locations)
• Trial ID: NCT07011186 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1/2 study gives investigational oral TQB3909 in combination with standard azacitidine to adults with myeloid malignancies including AML and MDS. Phase 1 will determine safety, tolerability, and a recommended dose while Phase 2 will look for signals of efficacy. Participants will have regular blood tests, bone marrow assessments, and monitoring for adverse events during treatment. The trial is conducted at several hospitals in China and enrolls adults with adequate organ function who can take oral medication.

Who should consider this trial

Good fit: Adults (≥18 years) with diagnosed myeloid malignancies such as AML or MDS, expected survival over three months, adequate major organ function, and the ability to take oral medication are ideal candidates.

Not a fit: Patients with another recent malignancy within three years, conditions that impair oral drug intake or absorption, recent major surgery or thrombotic events, uncontrolled psychiatric disease or substance abuse, or inability to use contraception may not benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could improve response rates or disease control for some patients with myeloid malignancies.

How similar studies have performed: Combining azacitidine with novel oral targeted agents has shown promise in other studies, but TQB3909 itself is a new investigational drug without large published results.

Eligibility criteria

Inclusion Criteria:

* Voluntary and signed informed consent, good compliance
* Age: ≥18 years old (at the time of signing the informed consent); expected survival time greater than 3 months.
* Diagnosis of one of the following diseases:

  1. Acute Myeloid Leukemia (AML):
  2. Myelodysplastic Syndromes (MDS)
  3. Major organ functions are normal.
  4. Fertile male and female subjects agree to use contraception during the study and for 6 months after the study ends.

Exclusion Criteria:

* Comorbidities and Medical History:

  1. Diagnosis of or current concomitant malignancy within 3 years prior to the first dose;
  2. Presence of multiple factors affecting oral drug intake and/or absorption;
  3. Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose;
  4. History of arterial/venous thrombotic events within 6 months prior to the first dose;
  5. History of psychiatric drug abuse that cannot be discontinued, or psychiatric disorders;
  6. Presence of any severe and/or uncontrolled disease in the subject.
* Tumor-related Symptoms and Treatment:

  1. Diagnosis of Acute Promyelocytic Leukemia (APL), Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN);
  2. Presence of leukemia central nervous system (CNS) involvement or high suspicion of CNS involvement but unable to confirm;
  3. Subjects with extramedullary disease only in AML;
  4. Presence of life-threatening severe leukemia-related complications;
* Study Treatment-related:

  1. Received live vaccines within 4 weeks prior to the first dose, or planned to receive live vaccines during the study period;
  2. Participated in other clinical trials involving anti-tumor drugs within 4 weeks prior to the first dose.

Where this trial is running

Bengbu, Anhui and 20 other locations

• The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China (Not_yet_recruiting)
• Beijing Chaoyang Hospital Affiliated to Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Peking University People's Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Affiliated Hospital of Chengde Medical University — Chengde, Hebei, China (Not_yet_recruiting)
• Harbin The First Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Not_yet_recruiting)
• Zhuzhou Central Hospita — Zhuzhou, Hunan, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Tai'an Central Hospital (Tai'an Central Hospital affiliated to Qingdao University, Mount Taishan Medical Center) — Taian, Shandong, China (Not_yet_recruiting)
• Zibo Central Hospital — Zibo, Shandong, China (Not_yet_recruiting)
• ShangHai Tongren Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai Pudong New Area People's Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• People's hospital of deyang city — Deyang, Sichuan, China (Not_yet_recruiting)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• People's Hospital of Tianjin (City) — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: JianXiang Wang, Master

Conditions Myeloid Malignancy