ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

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 progressivedisease

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.

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 havenot undergone surgical sterilization or who have not been naturally postmenopausalfor at least 12 consecutive months must agree to use two effective contraceptivemethods while on study treatment and for at least 7 months after the last dose ofADCE T02.

8. Male patients must agree to use condoms, even if they have had a successfulvasectomy, while on study treatment and for at least 4 months after the last dose ofADCE T02.

Key Exclusion Criteria:

1. Prior treatment with any agent targeting Tissue Factor or any ADC with atopoisomerase 1 payload

2. Central nervous system (CNS) metastasis.

3. Active ocular surface disease or a history of cicatricial conjunctivitis orinflammatory conditions that predispose to cicatrizing conjunctivitis, mucuspemphigoid 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 cardiacarrhythmias

7. History of (non-infectious) interstitial lung disease (ILD)/pneumonitis thatrequired steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis

8. Prior second malignancy except for:

• 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.