TQB3019 capsules for adults with advanced malignant tumors — safety and early effects

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3019 Capsules in Subjects With Advanced Malignant Tumors

This phase 1 trial will test whether TQB3019 capsules are safe and show early signs of benefit in adults with advanced malignant tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 15 sites (Beijing, Beijing Municipality and 14 other locations)
• Trial ID: NCT06943677 on ClinicalTrials.gov

What this trial studies

This phase 1, open-label, non-randomized, single-arm trial uses a dose-escalation stage followed by a dose-expansion stage to explore TQB3019's safety, tolerability, pharmacokinetics, and preliminary efficacy. Participants receive TQB3019 orally in either single-dose or continuous dosing regimens depending on cohort assignment, with regular monitoring for adverse events, drug levels, and tumor response. Eligible adults have recurrent or refractory advanced malignant tumors with at least one measurable lesion and adequate organ function. The study is conducted across major cancer centers in China to identify tolerated doses and early signals of antitumor activity to inform further development.

Who should consider this trial

Good fit: Adults (≥18 years) with recurrent or refractory advanced malignant tumors, ECOG performance status 0–2, an expected survival of at least 3 months, adequate organ function, and at least one measurable lesion are the intended participants.

Not a fit: Patients with other active malignancies within the past three years, inadequate organ function, pregnancy or lactation, or those unable to attend visits at the participating Chinese centers are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, TQB3019 could become a new treatment option that is safe and shows early antitumor activity for patients with advanced malignant tumors.

How similar studies have performed: Other first-in-human dose-escalation oncology trials have sometimes shown early responses with novel agents, but TQB3019's safety and efficacy remain unproven and require further study.

Eligibility criteria

Inclusion Criteria:

* Subjects voluntarily joined the study, signed informed consent form, and with good compliance.
* ≥18 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
* Clearly diagnosed recurrent / refractory hematological tumors that meet the World Health Organization (WHO) definition;
* At least 1 measurable lesion for efficacy evaluation.
* The function of main organs is normal.
* Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; a negative serum pregnancy test within 7 days prior to study enrollment and must be non-lactating subjects; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.

Exclusion Criteria:

* Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\].
* Subjects with central nervous system aggression (CNS);
* Received allogeneic hematopoietic stem cell transplantation (allo-HSCT) or had active graft-versus-host disease (GVHD) requiring immunosuppressive therapy within 12 months before the first dose;
* Multiple factors that affect the absorption of oral medications (e.g., inability to swallow, chronic diarrhea, and intestinal obstruction);
* Unrelieved toxicity of ≥CTC AE grade 1 due to any previous treatment, excluding alopecia and fatigue;
* Major surgical treatment, open biopsy, and significant traumatic injury were received within 28 days before the start of study treatment.
* The presence of active or uncontrolled primary autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP);
* Patients with evidence or history of bleeding constitution; Or any bleeding event (such as gastrointestinal bleeding) greater than or equal to CTC AE level 3 within 4 weeks before the first medication;
* Subjects had an arteriovenous thrombosis event within 6 months.
* Subjects have history of psychotropic substance abuse and are unable to abstain or have mental disorders;
* Subjects with any severe and/or uncontrolled disease.
* Within 2 weeks before the first treatment, the subjects had received proprietary Chinese medicines with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;
* Previously received treatment with drugs similar to TQB3019 capsules;
* Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (investigator judgment)
* Study treatment related: subjects received live or messenger RNA (mRNA) vaccines within 4 weeks before the first treatment or were scheduled to receive live or mRNA vaccines during the study;
* Participated in clinical trials of other antitumor drugs within 4 weeks before the first treatment;
* According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for enrollment for other reasons.

Where this trial is running

Beijing, Beijing Municipality and 14 other locations

• Cancer Institute & Hospital.Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Heze Municipal Hospital — Heze, Shandong, China (Not_yet_recruiting)
• The Cancer Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Not_yet_recruiting)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Not_yet_recruiting)
• Tongji Hospital of Tongji University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Not_yet_recruiting)
• Mianyang Central Hospital — Mianyang, Sichuan, China (Not_yet_recruiting)
• Affiliated Hospital of North sichuan Medical college — Nanchong, Sichuan, China (Not_yet_recruiting)
• TianJin Medical University Cancer Institute&Hospital — Tianjin, Tianjin Municipality, 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)

Study contacts

• Study coordinator: Zengjun Li, Doctor

Conditions Advanced Malignant Cancer