Trial NCT06597721
ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
- Phase
- Phase 1
- Sponsor
- Adcendo ApS
- Conditions
- Advanced Solid Tumor; PDAC; HNSCC
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Key Inclusion Criteria:
1. Patients must have pathologically confirmed unresectable advanced solid tumor
2. Patients who have undergone at least one systemic therapy and have progressive disease
3. Patients must have at least one measurable lesion as per RECIST version 1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.Performance status
5. Life expectancy ≥ 3 months.
6. Patients must have adequate organ function as indicated by laboratory values
7. Women of childbearing potential (WCBP), defined as sexually mature women who have not undergone surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while on study treatment and for at least 7 months after the last dose of ADCE T02.
8. Male patients must agree to use condoms, even if they have had a successful vasectomy, while on study treatment and for at least 4 months after the last dose of ADCE T02.
Key Exclusion Criteria:
1. Prior treatment with any agent targeting Tissue Factor or any ADC with a topoisomerase 1 payload
2. Central nervous system (CNS) metastasis.Brain metastases
3. Active ocular surface disease or a history of cicatricial conjunctivitis or inflammatory conditions that predispose to cicatrizing conjunctivitis, mucus pemphigoid or penetrating ocular transplants.
4. Persistent toxicities from previous systemic anti-neoplastic treatments
5. Known past or current coagulation defects leading to an increased risk of bleeding
6. Significant cardiac disease; recent myocardial infarction, acute coronary syndromes, congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmiasCardiac
7. History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis
8. Prior second malignancy except for:Prior malignancy
* Well treated basal cell carcinoma or squamous cell carcinoma of the skin.
* Low-risk prostate cancer with a Gleason score < 7 and a PSA level < 10 ng/mL
* Any cancer or in situ cancer the patient has been disease-free for ≥ 2 years.
Restrictions found (4)
- Brain metastasesOutrightexclusionShow in the text
- CardiacConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0-1
Show in the text - Prior malignancyConditionalexclusion
disease-free for >= 2 years for cancer or in situ cancer exceptions
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County