Solid Tumor CancersPhase 1/2APM-CT001NCT07688148

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

A Phase 1/2 study testing TAX2 in people with Solid Tumor Cancers, run by Apmonia Therapeutics at 4 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor Cancers
What is being tested?: TAX2
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 4 sitesin 2 countries
Study dates: Oct 2026to Aug 2030
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

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.

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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.

Who cannot join

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:
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.

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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.
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.
E.10 Known central nervous system (CNS) metastasis that is either untreated or treated but associated with clinical symptoms (e.g. headache, convulsions). Patients with CNS metastasis who were treated with radiotherapy and/or surgery are eligible if they have been without clinical symptoms and have demonstrated stability on MRI for at least 6 weeks prior to start of trial treatment; if under treatment with corticosteroids (not exceeding 10 mg/day prednisone or equivalent) and/or anticonvulsive agents, patients must be on stable doses for at least 2 weeks prior to start of trial treatment.
E.11 Requirement of therapy for active infections. All anti-infectious therapies must have been completed at least 7 days prior to start of trial treatment.
E.12 Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment; known active hepatitis A infection (defined as positive hepatitis A antigen or positive Immunoglobulin M (IgM)); active or chronic hepatitis B (HBV) or hepatitis C (HCV) infection. Participants with chronic HBV or HCV disease that is controlled under antiviral therapy are allowed. Hepatitis B and C serology will be tested at screening in all participants.
E.13 Active SARS-CoV-2 infection defined as having a positive SARS-CoV-2 PCR test at screening. The PCR test result must not be older than 72 hours prior to start of trial treatment. Completed vaccination or prior SARS-CoV-2 infection do not exempt from PCR testing.
E.14 Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of the investigational medicinal product (IMP). Non-live vaccines on routine vaccinations are recommended for the patients and their contacts. Prophylactic vaccination is recommended for influenza A and B virus, pneumococci and Haemophilus influenzae. Ribonucleic acid (RNA)-based vaccination for SARS-CoV-2 is also recommended.
E.15 History of allogeneic tissue and/or solid organ transplantation.
E.16 History of another primary malignancy except for:
Malignancy treated with curative intent, with no known active disease for at least 2 years prior to start of trial treatment, and with a relatively low risk for recurrence.
Adequately treated non-melanoma skin cancer or lentigo maligna without current evidence of disease.
Adequately treated carcinoma in situ (including ductal carcinoma of the breast, DCIS) without current evidence of disease.
Cancer subjects with incidental histologic findings of prostate cancer that, in the opinion of the Investigator, does not require active therapy (e.g. incidental prostate cancer identified following cysto-prostatectomy that is tumour/node/metastasis Stage < or equal to pT2N0) may be enrolled, pending discussion and approval by the Sponsor.
E.17 Concurrent enrolment in another clinical trial, unless it is an observational (non-interventional) clinical trial for the duration of this trial or the FU period of an interventional trial.
E.18 Use of any investigational agent within 4 weeks prior to start of trial treatment.
E.19 Any anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 4 weeks or 5 half-lives (for monoclonal antibodies) prior to start of trial treatment; however, the following are allowed:
Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists for prostate cancer.
Hormone-replacement therapy or oral contraceptives.
Palliative radiotherapy for bone metastases within 2 weeks prior to start of trial treatment.
E.20 Daily requirement for immunosuppressive therapy or corticosteroids (equivalent to > 10 mg/day prednisone) for more than 7

Trial locations and contacts

4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Country

City, postcode or hospital

4 sites in 2 countries

Belgium2 sites

Institut Jules Bordet
Brussels, 1070
Nuria Kotecki, Professor
Universitair Ziekenhuis Gent
Ghent, 9000
Sylvie Rottey, Professor

Other trials in Belgium

France2 sites

Centre Léon Bérard
Lyon, 69000
Philippe Cassier, Doctor
Institut Gustave Roussy
Villejuif, 94800
Alexandra Leary, Professor
Kaissa Ouali, Doctor

Other trials in France

About this study

Official title: A Phase 1/2a, First-in-human, Open-label, Dose-escalating Study With a Safety Expansion Cohort to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumour Activity of TAX2 in Patients With Relapsed/Refractory Advanced/Metastatic Solid Tumours

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
Being tested: TAX2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAX2Drug
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.

Study groups in NCT07688148
Study group	Role	What they receive
Patients with relapsed/refractory advanced/metastatic solid tumours will receive TAX2	Experimental	Not described Receives: Drug: TAX2

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

Characterisation of the Pharmacokinetic profile
Minimum (trough) concentration (Ctrough)
Measured: From enrollment to the end of treatment at 6 weeks
Pharmacodynamics (PD) markers
PD markers related to anti-tumour effects: Circulating markers of tumour response and Tissue markers of tumour response
Measured: From enrollment to the end of treatment at 6 weeks
Characterisation of the Pharmacokinetic Profile
Time of maximum (peak) concentration (tmax)
Measured: From enrollment to the end of treatment at 6 weeks
Characterisation of the Pharmacokinetic Profile
PK parameter Cmax
Measured: From enrollment to the end of treatment at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2026Aug 2030

First posted7 Jul 2026
Study startOct 2026 (estimated)
Primary completionFeb 2029 (estimated)
Study completionAug 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Tumor CancersStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 48 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07688148
Sponsor's protocol ID: APM-CT001
Other IDs: 2025-521164-36-00, 2025
Acronym: APM-CT001
Status last verified: Jun 2026
First submitted: 20 Apr 2026
Last updated: 7 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study on GD2 Positive Solid Tumors by 4SCAR-GD2
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The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
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All Solid Tumor Cancers trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1/2a, First-in-human, Open-label, Dose-escalating Study With a Safety Expansion Cohort to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Anti-tumour Activity of TAX2 in Patients With Relapsed/Refractory Advanced/Metastatic Solid Tumours
ClinicalTrials.gov ID: NCT07688148
Acronym / sponsor ID: APM-CT001 / APM-CT001
Conditions: Solid Tumor Cancers
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 48 participants (estimated)
Lead sponsor: Apmonia TherapeuticsIndustry (pharma, biotech, devices)
Study start: Oct 2026 (estimated)
Primary completion: Feb 2029 (estimated)
Study completion: Aug 2030 (estimated)
First posted: 7 Jul 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 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)

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with relapsed/refractory advanced/metastatic solid tumours will receive TAX2	Experimental	Drug: TAX2

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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.
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.

Key exclusion criteria (33 listed)

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.
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.

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
TAX2TAX2 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.	Drug	Patients with relapsed/refractory advanced/metastatic solid tumours will receive TAX2

Primary outcome

Number of patients with DLTs _ Phase 1
Time frame: From enrollment to the end of Cycle 1 (each cycle is 28 days)
A DLT is defined as any AE considered at least possibly treatment-related, occurring during treatment Cycle 1 (i.e. D1 to D28)
Safety and tolerability to be determined based on the frequency and number of patients with AEs
Time frame: From enrollment to the end of Cycle 1 (each cycle is 28 days)
Frequency, number of patients with AEs and intensity of AEs using CTCAE v6.0

4 secondary outcomes

Characterisation of the Pharmacokinetic profile
Time frame: From enrollment to the end of treatment at 6 weeks
Pharmacodynamics (PD) markers
Time frame: From enrollment to the end of treatment at 6 weeks
Characterisation of the Pharmacokinetic Profile
Time frame: From enrollment to the end of treatment at 6 weeks
Characterisation of the Pharmacokinetic Profile
Time frame: From enrollment to the end of treatment at 6 weeks

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 7 Jul 2026.
Individual participant dataSharing planned: No

Related trials for Solid Tumor Cancers

Not yet recruitingPhase 1/2
Study on GD2 Positive Solid Tumors by 4SCAR-GD2
Solid Tumor
Active, not recruitingPhase 2
Genetic Testing in Guiding Treatment for Patients With Brain Metastases
CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor

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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TAX2 in people with Solid Tumor Cancers, run by Apmonia Therapeutics at 4 sites in 2 countries.

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 15 inclusion and 33 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, France. 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 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with DLTs _ Phase 1 (time frame: From enrollment to the end of Cycle 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07688148.

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 7 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.