About this trial
This is a phase Ib/II exploratory study. Phase Ib includes the dose escalation and expansion study of monotherapy, as well as the dose escalation study of combination therapy. After determining the maximum tolerated dose (MTD), a dose expansion study is conducted to observe the safety and efficacy in monotherapy. Phase II study is to further observe the safety and efficacy of TQB2930 combined with albumin-paclitaxel (cohort 3), or chemotherapy selected by investigators (cohort 4).
Eligibility criteria
Qualifiers
Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0~1; The expected survival is over 3 months.
Phase Ib
Advanced malignancies confirmed by cytology / histopathology, priority given to subjects with HER2 expression or amplification;
Subjects with malignant tumors who have failed standard treatment or lack effective treatment;
Disqualifiers
Have occured other malignant tumors within 3 years prior to first dose.
Unalleviated toxicity above Common Terminology Criteria for Adverse Events (CTCAE) grade 1 due to any prior treatment;
Received major surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the first dose;
Long-term unhealed wounds or fractures;
Trial design
Treatments tested in this trial
- TQB2930 for injection
- Paclitaxel for injection (albumin-bound)
- TQB3616 capsule
- Fulvestrant injection
- Capecitabine tablets
- Vinorelbine tartrate injection
- Eribulin mesylate injection
- gemcitabine hydrochloride for injection