Advanced Solid TumorsPhase 1NCT07356453
A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors.
A Phase 1 study testing FORX-428 in people with Advanced Solid Tumors, run by FoRx Therapeutics AG at 8 sites in United States.
Trial summary
The goal of this interventional study is to evaluate the safety and tolerability of escalating doses of FORX-428 as monotherapy in patients with select advanced solid tumors with BRCA1/2 mutations or other DDR deficiencies or high replication stress, and to determine the maximum tolerated dose (MTD) and Recommended… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- FORX-428
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesUnited States
- Study dates
- 22 Jul 2025to Apr 2028
- 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
- Patient must be >/=18 years of age at time of signing informed consent;
- Patient has histologically and/or cytologically confirmed diagnosis of advanced or metastatic selected solid tumors.
- Patient must have progressed on at least 1 prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of care. In general, if maintenance therapy is part of the standard of care, it should be considered as part of the "1 prior line of therapy in the advanced or metastatic setting" requirement;
- Patient must fulfill genomic selection criteria: prior available documented evidence in tissue or blood (circulating tumor DNA [ctDNA]) of the genetic alterations indicated below. The Sponsor Medical Monitor or delegate must confirm eligibility based on the reported genomic alteration and applicable assay cut off criteria prior to patient enrollment.
- Patients with BRCA1/2 mutations (germline or somatic, pathogenic or likely pathogenic) and other mutations signifying HR deficiency or high replication stress.
- For Dose Expansion: Tumor types for Dose Expansion cohorts include a subset of tumors specified in Inclusion Criterion 3 as follows: i) Cohort 1: Advanced or metastatic breast cancer independent of hormone receptor status and documented evidence of prior treatment with a locally approved PARP inhibitor(s); ii) Cohort 2: Advanced or metastatic ovarian cancer with prior available documented evidence in tissue or blood (ctDNA) of specific genomic abnormalities.
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- Cohort 3: Advanced or metastatic breast cancer with prior available documented evidence in tissue or blood (ctDNA) of specific genomic abnormalities.
- Note: Diagnostic genetic testing for Dose Escalation/backfilling and Dose Expansion cohorts must meet the following requirements:
- United States (US): Testing must have been performed using a College of American Pathologists/Clinical Laboratory Improvement Amendments (CAP/CLIA)-certified laboratory developed test (LDT) or a Food and Drug Administration (FDA)-approved diagnostic test.
- Patient has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 at Clinical Screening; Note: Tumor lesions situated in a previously irradiated or otherwise locally treated area will be considered measurable provided that there has been clear imaging-based progression of the lesion since the time of local treatment.
- Patient has adequate bone marrow and organ function, defined by the following laboratory results obtained within 14 days before first dose of study drug:
- Platelet count >/=100 × 10^9/L (>/=100,000/μL) (absence of platelet transfusion within 1 week);
- Hemoglobin >/=90 g/L (>/=5.6 mmol/L) (absence of red blood cell transfusion within 2 weeks);
- Absolute neutrophil count >/=1.5 × 10^9/L (>/=1500/μL) (absence of growth factors within 2 weeks);
- Aspartate aminotransferase and alanine aminotransferase </=2.5 × upper limit normal (ULN) or </=5 × ULN for patients with liver metastases;
- Total bilirubin </=1.5 × ULN, or </=3.0 × ULN for patients with liver metastases or Gilbert's syndrome;
- Estimated glomerular filtration rate >/=60 mL/min calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration Equation; and
- Adequate coagulation test results defined by activated partial thromboplastin time </=1.5 × ULN, international normalized ratio (INR) </=2.0 with the exception of INR 2 to 3 acceptable for patients on warfarin anticoagulation or direct oral anticoagulants.
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 with >/=3 months of life expectancy for Dose Escalation cohorts, and an ECOG PS of 0 to 1 with >/=3 months of life expectancy for backfilling and Dose Expansion cohorts;
- Patient is able to swallow tablets and has no gastrointestinal conditions affecting absorption.
Who cannot join
- Patient has received anti-cancer treatment or an investigational agent </=14 days or 5 half-lives prior to first dose, whichever is shorter, or patient has received immunotherapy </=28 days prior to first dose; Note: Localized radiotherapy given with palliative intent is allowed and should be completed 1 week or more before receiving the first dose of FORX-428. It may also be allowed after the dose-limiting toxicity (DLT) Observation Period, pending discussion with the Sponsor Medical Monitor or delegate and their approval.
- Patient has had previous exposure to a PARG inhibitor;
- Patient has a history of other malignancy diagnosed </=5 years prior to consent, except for any locally occurring cancer that has been treated with curative intent with no evidence of disease for >2 years at the time of consent and includes the following: completely resected cervical carcinoma in situ, basal or squamous cell skin cancer, ductal carcinoma in situ, superficial bladder cancer, or early-stage prostate cancer which has been adequately treated;
- Patient has had major surgery within 30 days prior to first dose of study drug (with exceptions further defined in the protocol), or anticipation of major surgery during study treatment;
- Patient has impaired cardiovascular function or clinically significant cardiovascular disease as further stipulated in the protocol;
- Patient has uncontrolled HIV or hepatitis C infection;
- Patient has known metastatic central nervous system malignant disease or leptomeningeal disease; Note: Patients previously treated for brain metastasis who are asymptomatic, receiving </=10 mg/day prednisone equivalent, not requiring anti-epileptic therapy, and without evidence of radiological progression for at least 4 weeks are allowed.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
NEXT - Virginia Cancer Specialists
Fairfax, Virginia, 22031
Study Coordinator, 703-783-4510
- Recruiting
START - Midwest
Grand Rapids, Michigan, 49546
Study Coordinator, 616-954-5554
- Recruiting
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Study Coordinator, 866-541-1846
- Recruiting
Stanford University Medical Center
Palo Alto, California, 94304
Study Coordinator, 650-723-4000
- Recruiting
Knight Cancer Institute
Portland, Oregon, 97239
Study Coordinator, 503-494-8311
- Recruiting
START - San Antonio
San Antonio, Texas, 78229
Study Coordinator, 210-593-5250
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Study Coordinator, 888-689-8273
- Recruiting
Washington University St. Louis
St Louis, Missouri, 63108
Study Coordinator, 800-600-3606
About this study
Official title: A Phase 1 Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors With BRCA1/2 Mutations or Other DDR Deficiencies or High Replication Stress.
The goal of this interventional study is to evaluate the safety and tolerability of escalating doses of FORX-428 as monotherapy in patients with select advanced solid tumors with BRCA1/2 mutations or other DDR deficiencies or high replication stress, and to determine the maximum tolerated dose (MTD) and Recommended Cohort Expansion Dose (RCED) of FORX-428 as monotherapy.
Read the detailed description
The primary objective of the Expansion cohorts (Part 2) of this study is to evaluate the preliminary anti-tumor activity of FORX-428 as monotherapy.
Secondary Outcome Measures:
The secondary objectives of Part 1 of this study are the following:
- To evaluate the preliminary anti-tumor activity of FORX-428 as monotherapy;
- To evaluate the PK profile of FORX-428 when administered as monotherapy; and
- To evaluate a FORX-428-induced effect on heart rate-corrected QT interval (QTc).
The secondary objectives of Part 2 of this study are the following:
- To evaluate the safety and tolerability of FORX-428 as monotherapy; and
- To evaluate the PK profile of FORX-428 when administered as monotherapy.
- Conditions
- Advanced Solid Tumors
- Being tested
- FORX-428
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FORX-428Drug
FORX-428 drug product is formulated as immediate release tablets for oral administration in 3 dosage strengths containing 10 mg, 50 mg, and 100 mg FORX-428 drug substance.
| Study group | Role | What they receive |
|---|---|---|
| First-in-human single-arm, open-label, multicenter Phase 1 dose escalation/expansion cohort study. | Experimental | FORX 428 dose levels planned in the study: Dose Level 1: 30 mg, daily; Dose Level 2: 60 mg, daily; Dose Level 3: 120 mg, daily; Dose Level 4: 200 mg, daily; Dose Level 5: 300 mg, daily; and Dose Level 6: 400 mg, daily. Following the selection of the Recommended Cohort Expansion Dose during Part 1 of the study, new patients will be included in 3 cohorts, with simultaneous parallel enrollment. Patients will be allowed to continue to receive FORX-428 monotherapy until disease progression or unacceptable toxicity. Part 2 will include approximately up to 29 evaluable patients in each expansion cohort as determined by the Simon's optimal 2-stage design. In Stage 1 of each cohort of Part 2, a total number of 10 patients will be accrued. If there are 1 or fewer responses by RECIST version 1.1 among these 10 patients, further enrollment in that cohort will be halted for futility. Otherwise, an additional 19 patients will be accrued per cohort in Stage 2 of Part 2. Receives: Drug: FORX-428 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Phase: Incidence of Dose-Limiting Toxicities (DLTs)
Measured: 1 year.
Dose Escalation Phase: Incidence of treatment-emergent serious adverse events (TESAEs)
Measured: 1 year.
Dose Escalation Phase: Incidence and severity of Treatment-emergent adverse event (TEAEs) and laboratory abnormalities
Adverse events will be recorded and severity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 1 year.
Dose Escalation Phase: Incidence of treatment discontinuations and treatment modifications due to adverse events (AEs) and laboratory abnormalities
Measured: 1 year.
Dose Escalation Phase: Change in vital signs measurements, clinical laboratory assessment, 12-lead electrocardiograms (ECGs), physical examinations (including Eastern Cooperative Oncology Group [ECOG] Performance Status [PS]), and urinalyses
Measured: 1 year.
Dose Escalation Phase: Establishing the Maximum Tolerated Dose (MTD) and Recommended Cohort Expansion Dose (RCED) of FORX-428 administered as monotherapy
Measured: 1 year.
Dose Expansion Phase: Tumor response: Best Overall Response (BOR)
BOR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: 1 year.
Dose Expansion Phase: Tumor response: Overall Response Rate (ORR)
ORR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: 1 year.
Dose Expansion Phase: Tumor response: Disease Control Rate (DCR)
DCR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: 1 year.
Dose Expansion Phase: Tumor response: Progression-free Survival (PFS)
PFS will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: 1 year.
Dose Expansion Phase: Tumor response: Overall Survival (OS)
OS will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: 1 year.
Secondary outcomes (27)
Dose Escalation Phase: Tumor response: Overall Response Rate (ORR)
ORR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: 1 year.
Dose Escalation Phase: Tumor response: Best Overall Response (BOR)
BOR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: 1 year.
Dose Escalation Phase: Tumor response: Disease Control Rate (DCR)
DCR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: 1 year.
Dose Escalation Phase: Tumor response: best change in tumor size
Best change in tumor size will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: 1 year.
Dose Escalation Phase: Tumor response: Progression-free Survival (PFS)
Measured: 1 year.
Dose Escalation Phase: Tumor response: Overall Survival (OS)
Measured: 1 year.
Dose Escalation Phase: Determination of plasma concentrations of FORX-428
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma (maximum plasma concentration [Cmax])
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma (time to maximum concentration [Tmax])
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma area under the plasma concentration curve [AUC] from time 0 to the time of last quantifiable plasma concentration [AUC0 t]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma area under the plasma concentration curve [AUC] from time 0 to time τ [AUCτ]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma area under the plasma concentration curve [AUC] from time 0 to infinity [AUC∞]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma apparent first-order terminal elimination rate constant [λz]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma terminal elimination half-life [t½]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma mean residence time (MRT)
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma apparent clearance [CL/F]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma apparent volume of distribution [Vz/F]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma peak to trough fluctuation [PTF]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma ratio of AUC [RAUC]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma ratio of Cmax [RCmax]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma average plasma concentration at steady state [Css av]
Measured: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma trough plasma concentration [Ctrough]
Measured: 1 year.
Dose Escalation Phase: Determination of concentration-QTc
Measured: 1 year.
Dose Expansion Phase: Incidence of treatment-emergent serious adverse events (TESAEs) and laboratory abnormalities
Adverse events will be recorded and severity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 1 year.
Dose Expansion Phase: Incidence of treatment discontinuations and treatment modifications due to AEs and laboratory abnormalities
Measured: 1 year.
Dose Expansion Phase: Change in vital signs measurements, clinical laboratory assessment, 12-lead electrocardiograms (ECGs), physical examinations (including Eastern Cooperative Oncology Group [ECOG] Performance Status [PS]), and urinalyses
Measured: 1 year.
Dose Expansion Phase: PK parameters of FORX-428 when administered as monotherapy in plasma (Cmax, tmax, AUC0 t, AUCτ, AUC∞, λz, t½, MRT, CL/F, Vz/F, PTF, RAUC, RCmax, Css av, and Ctrough, as applicable)
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start22 Jul 2025
- Primary completionJun 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FoRx Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356453
- Sponsor's protocol ID
- FORX-428-101
- Status last verified
- Sep 2026
- First submitted
- 23 Dec 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors With BRCA1/2 Mutations or Other DDR Deficiencies or High Replication Stress.
- ClinicalTrials.gov ID
- NCT07356453
- Acronym / sponsor ID
- FORX-428-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- FoRx Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 21 Jan 2026 (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.
The goal of this interventional study is to evaluate the safety and tolerability of escalating doses of FORX-428 as monotherapy in patients with select advanced solid tumors with BRCA1/2 mutations or other DDR deficiencies or high replication stress, and to determine the maximum tolerated dose (MTD) and Recommended Cohort Expansion Dose (RCED) of FORX-428 as monotherapy.
Detailed description
The primary objective of the Expansion cohorts (Part 2) of this study is to evaluate the preliminary anti-tumor activity of FORX-428 as monotherapy.
Secondary Outcome Measures:
The secondary objectives of Part 1 of this study are the following:
- To evaluate the preliminary anti-tumor activity of FORX-428 as monotherapy;
- To evaluate the PK profile of FORX-428 when administered as monotherapy; and
- To evaluate a FORX-428-induced effect on heart rate-corrected QT interval (QTc).
The secondary objectives of Part 2 of this study are the following:
- To evaluate the safety and tolerability of FORX-428 as monotherapy; and
- To evaluate the PK profile of FORX-428 when administered as monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-in-human single-arm, open-label, multicenter Phase 1 dose escalation/expansion cohort study. | Experimental | Drug: FORX-428FORX 428 dose levels planned in the study: Dose Level 1: 30 mg, daily; Dose Level 2: 60 mg, daily; Dose Level 3: 120 mg, daily; Dose Level 4: 200 mg, daily; Dose Level 5: 300 mg, daily; and Dose Level 6: 400 mg, daily. Following the selection of the Recommended Cohort Expansion Dose during Part 1 of the study, new patients will be included in 3 cohorts, with simultaneous parallel enrollment. Patients will be allowed to continue to receive FORX-428 monotherapy until disease progression or unacceptable toxicity. Part 2 will include approximately up to 29 evaluable patients in each expansion cohort as determined by the Simon's optimal 2-stage design. In Stage 1 of each cohort of Part 2, a total number of 10 patients will be accrued. If there are 1 or fewer responses by RECIST version 1.1 among these 10 patients, further enrollment in that cohort will be halted for futility. Otherwise, an additional 19 patients will be accrued per cohort in Stage 2 of Part 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient must be >/=18 years of age at time of signing informed consent;
- Patient has histologically and/or cytologically confirmed diagnosis of advanced or metastatic selected solid tumors.
- Patient must have progressed on at least 1 prior line of therapy in the advanced or metastatic setting that is considered an appropriate standard of care. In general, if maintenance therapy is part of the standard of care, it should be considered as part of the "1 prior line of therapy in the advanced or metastatic setting" requirement;
- Patient must fulfill genomic selection criteria: prior available documented evidence in tissue or blood (circulating tumor DNA [ctDNA]) of the genetic alterations indicated below. The Sponsor Medical Monitor or delegate must confirm eligibility based on the reported genomic alteration and applicable assay cut off criteria prior to patient enrollment.
- Note: Diagnostic genetic testing for Dose Escalation/backfilling and Dose Expansion cohorts must meet the following requirements:
Key exclusion criteria (7 listed)
- Patient has received anti-cancer treatment or an investigational agent </=14 days or 5 half-lives prior to first dose, whichever is shorter, or patient has received immunotherapy </=28 days prior to first dose; Note: Localized radiotherapy given with palliative intent is allowed and should be completed 1 week or more before receiving the first dose of FORX-428. It may also be allowed after the dose-limiting toxicity (DLT) Observation Period, pending discussion with the Sponsor Medical Monitor or delegate and their approval.
- Patient has had previous exposure to a PARG inhibitor;
- Patient has a history of other malignancy diagnosed </=5 years prior to consent, except for any locally occurring cancer that has been treated with curative intent with no evidence of disease for >2 years at the time of consent and includes the following: completely resected cervical carcinoma in situ, basal or squamous cell skin cancer, ductal carcinoma in situ, superficial bladder cancer, or early-stage prostate cancer which has been adequately treated;
- Patient has had major surgery within 30 days prior to first dose of study drug (with exceptions further defined in the protocol), or anticipation of major surgery during study treatment;
- Patient has impaired cardiovascular function or clinically significant cardiovascular disease as further stipulated in the protocol;
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 |
|---|---|---|
| FORX-428FORX-428 drug product is formulated as immediate release tablets for oral administration in 3 dosage strengths containing 10 mg, 50 mg, and 100 mg FORX-428 drug substance. | Drug | First-in-human single-arm, open-label, multicenter Phase 1 dose escalation/expansion cohort study. |
Primary outcome
Dose Escalation Phase: Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 1 year.
Dose Escalation Phase: Incidence of treatment-emergent serious adverse events (TESAEs)
Time frame: 1 year.
Dose Escalation Phase: Incidence and severity of Treatment-emergent adverse event (TEAEs) and laboratory abnormalities
Time frame: 1 year.
Adverse events will be recorded and severity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Dose Escalation Phase: Incidence of treatment discontinuations and treatment modifications due to adverse events (AEs) and laboratory abnormalities
Time frame: 1 year.
Dose Escalation Phase: Change in vital signs measurements, clinical laboratory assessment, 12-lead electrocardiograms (ECGs), physical examinations (including Eastern Cooperative Oncology Group [ECOG] Performance Status [PS]), and urinalyses
Time frame: 1 year.
Dose Escalation Phase: Establishing the Maximum Tolerated Dose (MTD) and Recommended Cohort Expansion Dose (RCED) of FORX-428 administered as monotherapy
Time frame: 1 year.
Dose Expansion Phase: Tumor response: Best Overall Response (BOR)
Time frame: 1 year.
BOR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Dose Expansion Phase: Tumor response: Overall Response Rate (ORR)
Time frame: 1 year.
ORR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Dose Expansion Phase: Tumor response: Disease Control Rate (DCR)
Time frame: 1 year.
DCR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Dose Expansion Phase: Tumor response: Progression-free Survival (PFS)
Time frame: 1 year.
PFS will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Dose Expansion Phase: Tumor response: Overall Survival (OS)
Time frame: 1 year.
OS will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
27 secondary outcomes
Dose Escalation Phase: Tumor response: Overall Response Rate (ORR)
Time frame: 1 year.
Dose Escalation Phase: Tumor response: Best Overall Response (BOR)
Time frame: 1 year.
Dose Escalation Phase: Tumor response: Disease Control Rate (DCR)
Time frame: 1 year.
Dose Escalation Phase: Tumor response: best change in tumor size
Time frame: 1 year.
Dose Escalation Phase: Tumor response: Progression-free Survival (PFS)
Time frame: 1 year.
Dose Escalation Phase: Tumor response: Overall Survival (OS)
Time frame: 1 year.
Dose Escalation Phase: Determination of plasma concentrations of FORX-428
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma (maximum plasma concentration [Cmax])
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma (time to maximum concentration [Tmax])
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma area under the plasma concentration curve [AUC] from time 0 to the time of last quantifiable plasma concentration [AUC0 t]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma area under the plasma concentration curve [AUC] from time 0 to time τ [AUCτ]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma area under the plasma concentration curve [AUC] from time 0 to infinity [AUC∞]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma apparent first-order terminal elimination rate constant [λz]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma terminal elimination half-life [t½]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma mean residence time (MRT)
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma apparent clearance [CL/F]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma apparent volume of distribution [Vz/F]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma peak to trough fluctuation [PTF]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma ratio of AUC [RAUC]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma ratio of Cmax [RCmax]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma average plasma concentration at steady state [Css av]
Time frame: 1 year.
Dose Escalation Phase: PK parameters of FORX-428 when administered as monotherapy in plasma trough plasma concentration [Ctrough]
Time frame: 1 year.
Dose Escalation Phase: Determination of concentration-QTc
Time frame: 1 year.
Dose Expansion Phase: Incidence of treatment-emergent serious adverse events (TESAEs) and laboratory abnormalities
Time frame: 1 year.
Dose Expansion Phase: Incidence of treatment discontinuations and treatment modifications due to AEs and laboratory abnormalities
Time frame: 1 year.
Dose Expansion Phase: Change in vital signs measurements, clinical laboratory assessment, 12-lead electrocardiograms (ECGs), physical examinations (including Eastern Cooperative Oncology Group [ECOG] Performance Status [PS]), and urinalyses
Time frame: 1 year.
Dose Expansion Phase: PK parameters of FORX-428 when administered as monotherapy in plasma (Cmax, tmax, AUC0 t, AUCτ, AUC∞, λz, t½, MRT, CL/F, Vz/F, PTF, RAUC, RCmax, Css av, and Ctrough, as applicable)
Time frame: 1 year.
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 Sep 2026.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FORX-428 in people with Advanced Solid Tumors, run by FoRx Therapeutics AG at 8 sites in United States.
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 20 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Contact Jens Wuerthner, MD, PhD (+1 513-579-9911, FORX-428-101@medpace.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation Phase: Incidence of Dose-Limiting Toxicities (DLTs) (time frame: 1 year.). The study lists 11 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 Sep 2026.