CancerPhase 1/2ENHANCENCT05275374
XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation
A Phase 1/2 study testing XP-102 and Trametinib in people with Cancer and BRAF V600 Mutation, run by Xynomic Pharmaceuticals, Inc..
Trial summary
This is a first-in-human multi-center study which will be conducted in advanced malignant solid tumors patients. The solid tumor type is limited to melanoma, colorectal, non-small-cell lung, and thyroid cancer with positive BRAF V600 mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, BRAF V600 Mutation, Melanoma
- What is being tested?
- XP-102 and Trametinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 30 Dec 2028
- Phase
- Phase 1/2
- 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
- ≥18 years of age
- Advanced malignant solid tumor patients with a BRAF V600 mutation (limited to melanoma, colorectal cancer, non-small cell lung cancer, or thyroid cancer).
- Must have failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Prior treatment with BRAF inhibitors and/or MEK inhibitors is permitted；
- At least one measurable lesion (brain metastasis must not be the only measurable lesion) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1);
- ECOG performance status of 0 or 1;
- Expected survival ≥ 3 months;
Show all 11Show fewer
- Adequate liver, renal, coagulation, cardiac, and hematologic function.
- A negative pregnancy test if female patient is of reproductive potential.
- For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study.
- Patients must agree to, and be capable of, adhering to the study visit schedule and all other protocol requirements;
- Patients must understand and voluntarily sign the written informed consent form, before the initiation of any study-specific procedures in the trial.
Who cannot join
- Active central nervous system (CNS) lesions. However, patients with asymptomatic and brain metastases who received treatment (including targeted brain radiotherapy, surgical treatment, glucocorticoid or other treatments) without disease progression for ≥ 3 months are eligible.
- Patients who received radiotherapy, immunotherapy, hormone therapy, targeted therapy, biotherapy, traditional Chinese medicine therapy, chemotherapy or any clinical trial treatment within 14 days before the first dose.
- Patients who have persistent toxicity caused by previous chemotherapeutic drugs or radiotherapy has not recovered to lower than grade 2 (except hair loss) according to CTCAE version 5.0;
- Patients who are allergic to active substances or excipients of XP-102 or trametinib.
- Significant traumatic injury within 28 days before the first dose of the investigational drug, or if major surgery is anticipated during the course of study treatment;
- According to the judgment of the investigator, patients with dysphagia, or any gastrointestinal diseases that may affect drug absorption or activity;
Show all 11Show fewer
- Administration of strong inhibitors or inducers of CYP3A4 liver metabolic enzymes within 14 days before the first dose of the investigational drug;
- Patients who are receiving drugs that may prolong QT interval and unable or unwilling to stop treatment or switch to other alternative treatment before study enrollment;
- Symptomatic active fungal, bacterial and/or viral infections; including known HIV, active hepatitis B, active hepatitis C or active syphilis infection.
- Any poorly controlled disorders (such as serious mental, neurological, cardiovascular, respiratory, digestive, urinary, bleeding and coagulation, or other system diseases) that may significantly affect the clinical trial;
- Other situations not suitable for participation in the study as judged by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Dose-escalation and Expansion Phase I/IIa Study of XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation (ENHANCE)
This is a first-in-human multi-center study which will be conducted in advanced malignant solid tumors patients. The solid tumor type is limited to melanoma, colorectal, non-small-cell lung, and thyroid cancer with positive BRAF V600 mutation. This study is divided into three stages: Phase Ia: a dose-escalation phase of XP-102; Phase Ib: a dose-escalation and sample size expansion phase of XP-102 plus trametinib; Phase IIa: an expansion phase of XP-102 plus trametinib.
- Conditions
- Cancer, BRAF V600 Mutation, Melanoma, Colorectal Cancer, Thyroid Cancer, Nonsmall Cell Lung Cancer
- Being tested
- XP-102, Trametinib
- Medical subject headings
- Neoplasms, Melanoma, Colorectal Neoplasms, Thyroid Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XP-102Drug
XP-102 will be administered orally once or twice daily in a continuous regimen.
TrametinibDrug
Trametinib will be administered 2mg orally once a day.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - XP-102 Dose Escalation | Experimental | XP-102 Receives: Drug: XP-102 |
| Part 2 - XP-102 + Trametinib Dose Escalation | Experimental | XP-102 plus Trametinib Receives: Drug: XP-102; Drug: Trametinib |
| Part 3 - XP-102 + Trametinib Dose Expansion | Experimental | XP-102 plus Trametinib Receives: Drug: XP-102; Drug: Trametinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the safety of XP-102.
Number of participants with treatment related adverse events.
Measured: 28 days
Evaluate the pharmacokinetics of XP-102.
Blood plasma concentration.
Measured: 28 days
Establish maximum tolerated dose of XP-102.
Number of participants with dose limiting toxicity
Measured: 28 days
Secondary outcomes (4)
Evaluate the pharmacokinetics of XP-102 + trametinib.
Blood plasma concentration.
Measured: 28 days
Characterize tolerability of XP-102 in combination with trametinib.
Number of participants with dose limiting toxicity
Measured: 28 days
Evaluate the pharmacokinetics of XP-102 administered with food
Blood plasma concentration.
Measured: 4 days
Evaluate clinical activity/efficacy of XP-102.
Overall Response Rate with RECIST criteria v1.1.
Measured: Approximately every 8 weeks (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start31 Dec 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 221 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275374
- Sponsor's protocol ID
- XYN-701
- Acronym
- ENHANCE
- Status last verified
- Apr 2025
- First submitted
- 20 Feb 2022
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation and Expansion Phase I/IIa Study of XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation (ENHANCE)
- ClinicalTrials.gov ID
- NCT05275374
- Acronym / sponsor ID
- ENHANCE / XYN-701
- Conditions
- Cancer, BRAF V600 Mutation, Melanoma, Colorectal Cancer, Thyroid Cancer, Nonsmall Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 221 participants (estimated)
- Lead sponsor
- Xynomic Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 11 Mar 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 first-in-human multi-center study which will be conducted in advanced malignant solid tumors patients. The solid tumor type is limited to melanoma, colorectal, non-small-cell lung, and thyroid cancer with positive BRAF V600 mutation. This study is divided into three stages: Phase Ia: a dose-escalation phase of XP-102; Phase Ib: a dose-escalation and sample size expansion phase of XP-102 plus trametinib; Phase IIa: an expansion phase of XP-102 plus trametinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 - XP-102 Dose Escalation | Experimental | Drug: XP-102XP-102 |
| Part 2 - XP-102 + Trametinib Dose Escalation | Experimental | Drug: XP-102, Drug: TrametinibXP-102 plus Trametinib |
| Part 3 - XP-102 + Trametinib Dose Expansion | Experimental | Drug: XP-102, Drug: TrametinibXP-102 plus Trametinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥18 years of age
- Advanced malignant solid tumor patients with a BRAF V600 mutation (limited to melanoma, colorectal cancer, non-small cell lung cancer, or thyroid cancer).
- Must have failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Prior treatment with BRAF inhibitors and/or MEK inhibitors is permitted；
- At least one measurable lesion (brain metastasis must not be the only measurable lesion) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1);
- ECOG performance status of 0 or 1;
Key exclusion criteria (11 listed)
- Active central nervous system (CNS) lesions. However, patients with asymptomatic and brain metastases who received treatment (including targeted brain radiotherapy, surgical treatment, glucocorticoid or other treatments) without disease progression for ≥ 3 months are eligible.
- Patients who received radiotherapy, immunotherapy, hormone therapy, targeted therapy, biotherapy, traditional Chinese medicine therapy, chemotherapy or any clinical trial treatment within 14 days before the first dose.
- Patients who have persistent toxicity caused by previous chemotherapeutic drugs or radiotherapy has not recovered to lower than grade 2 (except hair loss) according to CTCAE version 5.0;
- Patients who are allergic to active substances or excipients of XP-102 or trametinib.
- Significant traumatic injury within 28 days before the first dose of the investigational drug, or if major surgery is anticipated during the course of study treatment;
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 |
|---|---|---|
| XP-102XP-102 will be administered orally once or twice daily in a continuous regimen. | Drug | Part 1 - XP-102 Dose Escalation, Part 2 - XP-102 + Trametinib Dose Escalation, Part 3 - XP-102 + Trametinib Dose Expansion |
| TrametinibTrametinib will be administered 2mg orally once a day. | Drug | Part 2 - XP-102 + Trametinib Dose Escalation, Part 3 - XP-102 + Trametinib Dose Expansion |
Primary outcome
Characterize the safety of XP-102.
Time frame: 28 days
Number of participants with treatment related adverse events.
Evaluate the pharmacokinetics of XP-102.
Time frame: 28 days
Blood plasma concentration.
Establish maximum tolerated dose of XP-102.
Time frame: 28 days
Number of participants with dose limiting toxicity
4 secondary outcomes
Evaluate the pharmacokinetics of XP-102 + trametinib.
Time frame: 28 days
Characterize tolerability of XP-102 in combination with trametinib.
Time frame: 28 days
Evaluate the pharmacokinetics of XP-102 administered with food
Time frame: 4 days
Evaluate clinical activity/efficacy of XP-102.
Time frame: Approximately every 8 weeks (up to 2 years)
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 10 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XP-102 and Trametinib in people with Cancer and BRAF V600 Mutation, run by Xynomic Pharmaceuticals, Inc..
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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Sophia Paspal, Ph.D. (610-405-5974, Sophia.paspal@xynomicpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the safety of XP-102. (time frame: 28 days). The study lists 3 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 10 Apr 2025.