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SX-682

Phase 1

Metastatic Castrate-Resistant Prostate Cancer (mCRPC) | Small molecule | Oncology |United Therapeutics Corporation|Last Updated: Apr 15, 2026

Target and mechanism

Molecular targetCXCR2, CXCR1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment78

FDA Designations

No designations recorded

Clinical trial landscape

SX-682 · 1 trial · 1 indication

Phase 1 1
NCT07002320Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate CancerMetastatic Castrate-Resistant Prostate Cancer (mCRPC)
RECRUITING78 Analytics
PHASE1RECRUITING
Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer
Metastatic Castrate-Resistant Prostate Cancer (mCRPC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Biologically active and tolerable dose range
From start of treatment to end of Cycle 2 Day 1 (each cycle is 28 days)

The biological active and tolerable combination doses are those that satisfy observed DLT rate\<33% and demonstrate reduction in myeloid derived suppressor cells (MDSCs).

Anti-tumour activity of SX-682 when administered with Apalutamide
24 months

Response rate on the basis of Prostate Cancer Working Group 3 (PCWG3), and/or Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.

Secondary Endpoints

Safety and tolerability profile as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
12 months
Steady state pharmacokinetic parameters (CSSmin and CSSMax)
At the end of Cycle 2 Day 1 (each cycle is 28 days).
Number of patients with Prostate Specific Antigen (PSA) decline greater than 50%
24 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase I: Dose EscalationEXPERIMENTALPhase I will identify a biologically active and tolerable (safe) dose range of SX-682 in combination with Apalutamide in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Phase II: Dose ExpansionEXPERIMENTALPhase I will investigate the anti-tumour activity of tolerable doses of SX-682 in combination with Apalutamide in patients with metastatic castrate-resistant prostate cancer (mCRPC). Patients will be treated at dose levels deemed to be tolerable and biologically active, based on safety and efficacy data from Dose Escalation.

Interventions

NameTypeDescription
SX-682DRUGSX-682 is supplied as 100mg film coated tablets.
ApalutamideDRUGApalutamide is supplied as 60mg film coated tablets.
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Written informed consent and be capable of cooperating with treatment. 2. Age ≥ 18 years. 3. Histologically or biochemically confirmed adenocarcinoma of the prostate and with tumour tissue accessible for research analysis for this trial. Patients who have no histological diag...

Countries:SwitzerlandUnited Kingdom
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Frequently asked questions about SX-682

What is SX-682 used for?

SX-682 is an investigational small molecule being studied for the treatment of metastatic castrate-resistant prostate cancer (mCRPC). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does SX-682 target?

SX-682 is a small molecule that targets the CXCR1 and CXCR2 chemokine receptors. By inhibiting these receptors, it may modulate the tumor microenvironment and enhance anti-tumor immune responses in metastatic castrate-resistant prostate cancer.

Who makes SX-682?

SX-682 is being developed by United Therapeutics Corporation, a publicly traded company listed on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is SX-682 in?

SX-682 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing trial is recruiting patients with metastatic castrate-resistant prostate cancer.

What clinical trials is SX-682 in?

SX-682 is being evaluated in a Phase 1 clinical trial with the identifier NCT07002320. This study is investigating SX-682 in combination with apalutamide in patients with metastatic castration-resistant prostate cancer. The trial is currently recruiting participants in Switzerland and the United Kingdom.

Is SX-682 the same as apalutamide?

No, SX-682 is not the same as apalutamide. SX-682 is an investigational small molecule that targets CXCR1 and CXCR2, while apalutamide is an approved androgen receptor inhibitor. In the ongoing clinical trial, SX-682 is being studied in combination with apalutamide.