Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Apmonia Therapeutics (Voir sur ClinicalTrials)
octobre 2026
août 2030
29 octobre 2026
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)
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Kaissa OUALI | 30/10/2026 00:10:02 | Contacter | ||
Critères
Tous
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:
1. 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.
2. Relapsed/refractory metastatic colorectal cancer (mCRC). All histological types of
CRC are eligible.
3. Relapsed/refractory metastatic pancreatic cancer (mPC). All histological types of PC
are eligible, with the exception of pancreatic neuro-endocrine tumours.
4. 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):
1. 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.
2. 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.
3. 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.
4. 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.
Exclusion Criteria:
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:
1. Evidence of poorly controlled arterial hypertension (systolic blood pressure > 160
mm Hg or diastolic blood pressure > 100 mm Hg).
2. 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.
3. Any cardiac arrhythmia that is not well controlled.
4. Clinically significant valvular heart disease.
5. 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:
1. 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.
2. Adequately treated non-melanoma skin cancer or lentigo maligna without current
evidence of disease.
3. Adequately treated carcinoma in situ (including ductal carcinoma of the breast,
DCIS) without current evidence of disease.
4. 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:
1. Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists
for prostate cancer.
2. Hormone-replacement therapy or oral contraceptives.
3. 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