RET-altered Solid TumorsPhase 1NCT05653869
A Study of APS03118 in Advanced Solid Tumors Harboring RET Mutations or Fusions
A Phase 1 study testing APS03118 in people with RET-altered Solid Tumors, run by Applied Pharmaceutical Science, Inc. at 1 site in China.
Trial summary
This is a Phase 1/1b, 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RET-altered Solid Tumors
- What is being tested?
- APS03118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2023to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 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);
- 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
- Adequate organ function
Who cannot join
- Have a locally advanced solid tumor that is a candidate for curative surgery treatment through radical surgery and/or radiotherapy.
- Have an active fungal, bacterial, and/or active untreated viral infection
- The patient has a serious pre-existing medical condition(s)
- Have received or will receive a COVID-19 vaccine within 1 month before the first dose of APS03118.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APS03118 in Adult Patients With Unresectable Locally Advanced or Metastatic Solid Tumors Harboring RET Mutations or Fusions
This is a Phase 1/1b, 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.
Read the 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.
- Conditions
- RET-altered Solid Tumors
- Being tested
- APS03118
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APS03118Drug
Also called APS03118 administrated orally
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.
| Study group | Role | What they receive |
|---|---|---|
| APS03118 Dose Escalation | Experimental | APS03118 administered orally Receives: Drug: APS03118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLTs during Cycle 1 in dose-escalation cohorts
Measured: Within the 28 days of the first APS03118 dose for each patient
The maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D)
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)
Measured: Approximately 15 months
Secondary outcomes (10)
Adverse events(AE)
Measured: Approximately 24 months
Peak Plasma Concentration (Cmax)
Measured: Up to approximately 1 month
Area under the plasma concentration versus time curve (AUC)
Measured: Up to approximately 1 month
Time to Maximum Concentration (Tmax)
Measured: Up to approximately 1 month
Degree of accumulation
Measured: Up to approximately 1 month
Overall Response Rate (ORR)
As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Measured: Up to approximately 24 months
Duration of response (DOR)
Measured: Up to approximately 24 months
Best of response (BOR)
Measured: Up to approximately 24 months
Disease Control Rate (DCR)
Measured: Up to approximately 24 months
Progress Free Survival (PFS)
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start6 Feb 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RET-altered Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Applied Pharmaceutical Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653869
- Sponsor's protocol ID
- APS-RET-102
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of APS03118 in Adult Patients With Unresectable Locally Advanced or Metastatic Solid Tumors Harboring RET Mutations or Fusions
- ClinicalTrials.gov ID
- NCT05653869
- Acronym / sponsor ID
- APS-RET-102
- Conditions
- RET-altered Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Applied Pharmaceutical Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1/1b, 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.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APS03118 Dose Escalation | Experimental | Drug: APS03118APS03118 administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- 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);
- 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
Key exclusion criteria (4 listed)
- Have a locally advanced solid tumor that is a candidate for curative surgery treatment through radical surgery and/or radiotherapy.
- Have an active fungal, bacterial, and/or active untreated viral infection
- The patient has a serious pre-existing medical condition(s)
- Have received or will receive a COVID-19 vaccine within 1 month before the first dose of APS03118.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APS03118Also: APS03118 administrated orallyParticipant received APS03118 orally until evidence of unacceptable toxicity, progressed disease, consent withdrawal or with drawl from the study at the discretion of the investigator. | Drug | APS03118 Dose Escalation |
Primary outcome
Incidence of DLTs during Cycle 1 in dose-escalation cohorts
Time frame: Within the 28 days of the first APS03118 dose for each patient
The maximum tolerated dose (MTD) and / or recommended Phase II dose (RP2D)
Time frame: 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)
10 secondary outcomes
Adverse events(AE)
Time frame: Approximately 24 months
Peak Plasma Concentration (Cmax)
Time frame: Up to approximately 1 month
Area under the plasma concentration versus time curve (AUC)
Time frame: Up to approximately 1 month
Time to Maximum Concentration (Tmax)
Time frame: Up to approximately 1 month
Degree of accumulation
Time frame: Up to approximately 1 month
Overall Response Rate (ORR)
Time frame: Up to approximately 24 months
Duration of response (DOR)
Time frame: Up to approximately 24 months
Best of response (BOR)
Time frame: Up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Up to approximately 24 months
Progress Free Survival (PFS)
Time frame: Up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing APS03118 in people with RET-altered Solid Tumors, run by Applied Pharmaceutical Science, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLTs during Cycle 1 in dose-escalation cohorts (time frame: Within the 28 days of the first APS03118 dose for each patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.