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UI-102

Phase 1

Advanced Cancer | Small molecule | Oncology |United Therapeutics Corporation|Last Updated: Jun 3, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

UI-102 · 1 trial · 1 indication

Phase 1 1
NCT07605962Phase 1/2 Study of UI-102 in Selected Advanced CancersAdvanced Cancer
RECRUITING140 Analytics
PHASE1RECRUITING
Phase 1/2 Study of UI-102 in Selected Advanced Cancers
Advanced CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose Escalation: Percentage of participants with ≥1 dose-limiting toxicity (DLT)
Up to 24 months
Dose Escalation: Percentage of participants with ≥1 adverse event (AE)
Up to 24 months
Dose Escalation: Percentage of participants with ≥1 serious adverse event (SAE)
Up to 24 months
Dose Escalation: Percentage of participants with significant changes in electrocardiogram (ECG) recordings
Up to 24 months
Dose Escalation: Percentage of participants with significant changes in vital signs
Up to 24 months
Dose Escalation: Percentage of participants with significant changes in laboratory results
Up to 24 months
Dose Escalation: Percentage of participants with a dose interruption, reduction, or discontinuation
Up to 24 months
Expansion: Best Overall Response (BOR) as Determined by RECIST v1.1
Up to 48 months

Secondary Endpoints

Dose Escalation: Best Overall Response (BOR) as Determined by RECIST v1.1 with Monotherapy and in Combination
Up to 48 months
Dose Escalation: Duration of Response (DOR) as Determined by RECIST v1.1 with I Monotherapy and in Combination
Up to 48 months
Dose Escalation: Progression-free survival (PFS) as Determined by RECIST v1.1 with Monotherapy and in Combination
Up to 48 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
UI-102 Monotherapy, IV infusionEXPERIMENTALUI-102 monotherapy administered intravenously. This arm includes Phase I dose escalation, backfill cohorts, and cohort expansion in participants with selected locally advanced and/or metastatic solid tumors.
UI-102 Combination Therapy, IV infusionEXPERIMENTALUI-102 administered intravenously in combination with standard-of-care agents commonly used. This arm includes dose escalation, dose optimization, and cohort expansion.

Interventions

NameTypeDescription
UI-102DRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, * 18 Years and Older (adult, older adult), * Histologically confirmed advanced cancer, * Archived or fresh tumor tissue sample that must be confirmed as adequate, * Evaluable/Measurable disease per R...

Countries:United States
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Competitive Landscape -Cancer 5 trials (matched to "Advanced Cancer")

Frequently asked questions about UI-102

What is UI-102 used for?

UI-102 is an investigational small molecule being developed for the treatment of advanced cancer. It is currently in Phase 1 clinical development, with a Phase 1/2 study evaluating its use in selected advanced cancers. The drug is not yet approved and is still being tested in clinical trials.

Who makes UI-102?

UI-102 is being developed by United Therapeutics Corporation, a biotechnology company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the safety and efficacy of UI-102 in patients with advanced cancer.

What phase is UI-102 in?

UI-102 is currently in Phase 1 clinical development. A Phase 1/2 study is recruiting participants to evaluate the drug in selected advanced cancers. As an investigational agent, UI-102 has not yet received regulatory approval and is still undergoing clinical testing.

What clinical trials is UI-102 in?

UI-102 is being studied in a Phase 1/2 clinical trial with the identifier NCT07605962, titled 'Phase 1/2 Study of UI-102 in Selected Advanced Cancers.' This trial is currently recruiting participants in the United States and aims to enroll approximately 140 patients with advanced cancer.

Is UI-102 FDA approved?

No, UI-102 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The ongoing Phase 1/2 trial is evaluating its safety and efficacy in patients with advanced cancer, but regulatory approval has not been granted.