Health TrialsbyHealthPanel

A Study of HQP1351 in Patients With GIST or Other Solid Tumors

ConditionsGastrointestinal Stromal Tumor (GIST)Solid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorAscentage Pharma Group Inc.

About this trial

This study is a Multi-center, Open-label Phase 1 Study to Determine the Recommend Phase 2 Dose (RP2D) and Evaluate PK/PD and preliminary Efficacy of HQP1351 in Patients With GIST or Other Solid Tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or not pregnant or lactating women, age≥12years.

Advanced and/or metastatic GIST or other solid tumors, confirmed by histology and/or cytology. GIST patients must be primary resistant to imatinib (tumor progresses within 6 months first-line imatinib treatment, or succinate dehydrogenase B (SDHB) deficient confirmed by immunohistochemistry, or NF1 mutation), OR imatinib or imatinib and at least one other TKI treatment failure (after imatinib or other TKI treatment for more than 6 months, tumor progress again after achieving tumor remission or stability).

ECOG≤ 2.

Estimated survival at least 3 months.

Disqualifiers

Received any anti-cancer chemotherapy, biological agent treatment (e.g. Monoclonal antibody), immunotherapy (e.g. IFN) or radiotherapy with 28 days or 5 times half- time before first dose of HQP1351.

Received any TKIs within 14 days before first dose of HQP1351.

Attended any clinical trials on other drugs within 14 days before first dose of HQP1351.

Have not recovered (> Grade 1 by CTCAE, v. 4.0) from AEs (except alopecia) due to agents previously administered.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HQP1351

    Drug

    HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: HQP1351 30mgExperimental treatment 1 intervention
Group B: HQP1351 40mgExperimental treatment 1 intervention
Group C: HQP1351 50mgExperimental treatment 1 intervention
Group D: HQP1351 20mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerance

Patients with HQP1351 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03.

Time frame
30 days after the last dose of HQP1351

Secondary outcomes

1

Maximum plasma concentration (Cmax) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1.

Pharmacokinetic evaluation

Time frame
28 days
2

Area under the plasma concentration versus time curve (AUC) of HQP1351 on Day 1 and Day 27 post HQP1351 treatment on cycle 1.

Pharmacokinetic evaluation

Time frame
28 days
3

Anti-tumor activities of HQP1351

Response will be evaluated every 2 cycles (8 weeks), according to the revised RECIST Guideline, Version 1.1

Time frame
3-60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ascentage Pharma Group Inc.

Lead sponsor

HealthQuest Pharma Inc.

Collaborator

Source ClinicalTrials.gov
Apply now