A Study of APS03118 in Advanced Solid Tumors Harboring RET Mutations or Fusions
Study Details
Study Description
Brief Summary
This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antineoplastic activity of APS03118 administered orally in participants with RET-altered solid tumors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
After being informed about the study procedure and potential risks and benefits, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. The eligible participants will be enrolled using a rolling 6 dose escalation scheme to identify MTD and/or RP2D.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: APS03118 Dose Escalation APS03118 administered orally |
Drug: APS03118
Participant received APS03118 orally until evidence of unacceptable toxicity, progressed disease, consent withdrawal or with drawl from the study at the discretion of the investigator.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Incidence of DLTs during Cycle 1 in dose-escalation cohorts [Within the 28 days of the first APS03118 dose for each patient]
- The maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D) [Approximately 15 months]
The MTD is defined as the maximum dose at which the incidence of dose-limiting toxicities (DLTs) during Cycle 1 is below 30%(<2/6)
Secondary Outcome Measures
- Adverse events(AE) [Approximately 24 months]
- Peak Plasma Concentration (Cmax) [Up to approximately 1 month]
- Area under the plasma concentration versus time curve (AUC) [Up to approximately 1 month]
- Time to Maximum Concentration (Tmax) [Up to approximately 1 month]
- Degree of accumulation [Up to approximately 1 month]
- Overall Response Rate (ORR) [Up to approximately 24 months]
As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- Duration of response (DOR) [Up to approximately 24 months]
- Best of response (BOR) [Up to approximately 24 months]
- Disease Control Rate (DCR) [Up to approximately 24 months]
- Progress Free Survival (PFS) [Up to approximately 24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female patients aged 18 years or older
-
Have histological or cytological confirmation of unresectable locally advanced or metastatic solid tumors harboring oncogenic RET mutations or fusions confirmed by NGS. Site may identify patients with a RET-mutated or RET-fusion solid tumor before the formal screening.
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Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
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Resolution of all toxic effects of prior therapies to Grade 1 or below according to NCI CTCAE version 5.0 (except alopecia or Grade 2 neuropathy);
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Patients with asymptomatic brain metastases if they have been previously treated, demonstrated no progression at least for 1 months before Screening, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before Screening
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Adequate organ function
Exclusion Criteria:
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Have a locally advanced solid tumor that is a candidate for curative surgery treatment through radical surgery and/or radiotherapy.
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Have an active fungal, bacterial, and/or active untreated viral infection
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The patient has a serious pre-existing medical condition(s)
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Have received or will receive a COVID-19 vaccine within 1 month before the first dose of APS03118.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Chest Hospital | Shanghai | Shanghai | China | 200030 |
Sponsors and Collaborators
- Applied Pharmaceutical Science, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APS-RET-102