A First-in-human Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumour Activity of TAX2 in Patients With Relapsed/Refractory Advanced/Metastatic Solid Tumours

NCT07688148 | Not Yet Recruiting Phase 1 DMC

• 2 other identifiers: APM-CT0012025-521164-36-00
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this clinical trial is to investigate the treatment for adult patients suffering from advanced or metastatic solid tumours and has 2 parts to the study: the Phase 1 where ascending doses of the experimental study drug, TAX2, will be tested and the Phase 2a where all the participants will receive the study drug at the same dose considered as the recommended Phase 2 dose from Phase 1 part. The participation in the Phase 1 or in the Phase 2a part depends on when the participant is proposed to join the study. The study purpose is to assess:

• How safe and tolerable TAX2 is. This assessment will be based on the adverse effects collected during the study.
• How well TAX2 enters the body, circulates in the body, and leaves the body (known as pharmacokinetics, PK) by measuring the level of the drug in the blood
• What the drug does with the body and the tumour (known as pharmacodynamics, PD)
• The effect TAX2 has on the tumours (anti-tumour activity)
• Also define the Dose Limiting Toxicity (DLT) and the recommended Phase 2 Dose (RP2D)

Conditions

Solid Tumor Cancers

Outcome Measures

Primary Outcomes (2)

• Number of patients with DLTs _ Phase 1

  A DLT is defined as any AE considered at least possibly treatment-related, occurring during treatment Cycle 1 (i.e. D1 to D28)

  From enrollment to the end of Cycle 1 (each cycle is 28 days)

• Safety and tolerability to be determined based on the frequency and number of patients with AEs

  Frequency, number of patients with AEs and intensity of AEs using CTCAE v6.0

  From enrollment to the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (4)

• Characterisation of the Pharmacokinetic profile

  From enrollment to the end of treatment at 6 weeks

• Pharmacodynamics (PD) markers

  From enrollment to the end of treatment at 6 weeks

• Characterisation of the Pharmacokinetic Profile

  From enrollment to the end of treatment at 6 weeks

• Characterisation of the Pharmacokinetic Profile

  From enrollment to the end of treatment at 6 weeks

Study Arms (1)

Patients with relapsed/refractory advanced/metastatic solid tumours will receive TAX2

EXPERIMENTAL

Drug: TAX2

Interventions

TAX2 DRUG

TAX2 will be administered once weekly (qw) on days D1, D8, D15 and D22 of repeated 28-day treatment cycles. Treatment continues until disease progression, unacceptable toxicity or patient withdrawal, whichever comes first.

Patients with relapsed/refractory advanced/metastatic solid tumours will receive TAX2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I.01 Age ≥ 18 years. I.02 Patient capable of and willing to giving signed informed consent, which includes compliance with the requirements and restrictions listed in this protocol.
• I.03 Documented diagnosis of:
• Relapsed/refractory advanced/metastatic ovarian cancer (aOC). All histological types of OC are eligible, including ovarian clear cell carcinoma and with exception of mucinous ovarian subtypes.
• Relapsed/refractory metastatic colorectal cancer (mCRC). All histological types of CRC are eligible.
• Relapsed/refractory metastatic pancreatic cancer (mPC). All histological types of PC are eligible, with the exception of pancreatic neuro-endocrine tumours.
• Relapsed/refractory cutaneous metastatic melanoma (MM). All histological types of cutaneous melanoma are eligible.
• I.04 Must have received prior therapy for advanced/metastatic disease according to standard of care and have exhausted all therapeutic options.
• I.05 Must have documented evidence of progressive disease on or after the last treatment regimen.
• I.06 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• I.07 Willing to undergo paired tumour biopsies at screening and after 2 treatment cycles (optional: additional biopsy after 6 treatment cycles). Available tumour tissue from a non-irradiated tumour lesion biopsied within 6 weeks to start of trial treatment is acceptable as substitute for the screening biopsy, provided there has been no intervening treatment since the biopsy.
• I.08 Patients willing to use highly effective contraception as described below (in consistency with local regulations regarding the methods of contraception for clinical trial participants):
• A male participant must agree to use highly effective contraception (as described below) from the time of screening to at least 3 months after the last dose of trial treatment. During this period, he must refrain from donating sperm.
• A female participant must not be pregnant nor breastfeeding and either is not a woman of childbearing potential (WOCBP; i.e. not post-menopausal for ≥ 1 year and not surgically sterile) or must agree to use highly effective contraception (as described below) from the time of screening to at least 6 months after the last dose of trial treatment. During this period, she must refrain from participation in in vitro fertilisation.
• A WOCBP must agree to repeated pregnancy testing during trial participation. She must have a negative serum pregnancy test (beta-HCG) within 48 hours prior to start of trial treatment.
• Highly effective contraception includes combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, and/or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner or sexual abstinence.

You may not qualify if:

• E.01 Known intolerance or hypersensitivity to any of TAX2 formulation excipients or to dextrose.
• E.02 Prior treatment with any anti-CD47 or anti-SIRPα agent. E.03 Prior exposure (for up to 4 months or 5 half-lives, whichever is longer) to PD 1/PD L1 therapies.
• E.04 History or presence of autoimmune disease, except for autoimmune endocrinopathies that are stable on hormone replacement therapy.
• E.05 History or presence of inflammatory disease such as colitis, liver fibrosis, cirrhosis, interstitial fibrosis or chronic obstructive pulmonary disease.
• E.06 Inadequate haematological, hepatic and renal functions, as demonstrated by:
• a. Haematology: i. Platelet count ≤ 100,000 cells/mm3 ii. Absolute neutrophil count (ANC) ≤ 1,500 cells/mm3 iii. Haemoglobin ≤ 9 g/dL b. Coagulation: i. International normalized ratio (INR) \> 1.5 ii. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≥ 1.6 x ULN unless therapeutically warranted c. Serum creatinine \> 1.5 x upper limit of normal (ULN) or creatinine clearance ≤ 50 mL/min based on modification of diet in renal disease (MDRD) glomerular filtration rate estimation d. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x ULN, except in patients with liver metastasis: for these patients, AST or ALT \< or equal to 5 x ULN is acceptable for trial participation.
• e. Bilirubin \> 1.5 x ULN, except for patients with documented familial hyperbilirubinemia (such as Gilbert's syndrome): for these patients, a total bilirubin of \< 3 x ULN is acceptable for trial participation.
• f. Serum albumin \< 25 g/L
• E.07 History or presence of clinically significant cardiovascular disease with at least one of the following criteria:
• Evidence of poorly controlled arterial hypertension (systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg).
• Documented history of congestive heart failure of New York Heart Association Grade III or IV or presence of left ventricular ejection fraction (LVEF) of \< 50% during echocardiography or MUGA scan at screening.
• Any cardiac arrhythmia that is not well controlled.
• Clinically significant valvular heart disease.
• Unstable angina pectoris within 6 months prior to start of trial treatment. E.08 History or presence of severe dyspnoea, pulmonary dysfunction, or need for continuous supportive oxygen inhalation.
• E.09 History of severe peripheral vascular (arterial or venous) disease, including aneurysm, deep venous thromboembolic disease (DVT) within 6 months from screening, peripheral venous thrombosis within 4 months from screening, arterial thrombosis within 6 months from screening, myocardial infarction, pulmonary embolism or cerebrovascular accident. Patients with a history of DVT, peripheral venous or arterial thrombosis must be controlled under adequate anticoagulation before the beginning of the study.

Sponsors & Collaborators

• Apmonia Therapeutics: lead

Study Sites (4)

Institut Jules Bordet

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Centre Léon Bérard

Lyon, 69000, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: July 7, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); FR (2)