Advanced Solid Tumor, HNSCC, PDAC
Conditions
Brief summary
Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors. The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels. The expansion phase is now open for enrollment in indications including HNSCC and PDAC.
Interventions
DRUGADCE-T02
Administered intravenously
Sponsors
Adcendo ApS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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. 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. 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 arrhythmias 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: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) of ADCE-T02 | Up to 24 months | The MTD will be determined using DLTs |
| Recommended Expansion Phase Dose (RED) of ADCE-T02 | Up to 24 months | The RED will be determined using dose limiting toxicities (DLTs) and all other available study data |
| Type, incidence and severity of Adverse Events | Up to 24 months | Safety and tolerability profile of ADCE-T02 assessed by the Common Terminology Criteria for Adverse Events v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 24 months | Proportion of patients achieving Complete Response (CR) or Partial Response (PR) |
| Disease Control Rate (DCR) according to the RECIST v1.1 | Up to 24 months | Proportion of patients achieving CR, PR or Stable Disease (SD) |
| Progression-free Survival (PFS) | Up to 24 months | Time from date of start of treatment to date of the first progression or death, whichever occurs first. |
| Concentration of anti-drug antibodies (ADA) | Up to 24 months | Immunogenicity profile characterized by concentration of ADAs |
| Maximum observed concentration (C[max]) | Up to 24 months | Pharmacokinetic profile characterized by the maximum observed concentration (C\[max\]) of ADCE-T02 |
| Area under the curve (AUC) | Up to 24 months | Pharmacokinetic profile characterized by the area under the curve (AUC) of ADCE-T02 |
| Terminal half-life (t[1/2]) | Up to 24 months | Pharmacokinetic profile characterized by the terminal half-life (t\[1/2\]) of ADCE-T02 |
| Time to maximum concentration (Tmax) | Up to 24 months | Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) |
Countries
Australia, United States
Contacts
CONTACTSherri Paxton
CONTACTSarah Berardini
Outcome results
None listed