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First-in-Human Study of ADCE-D01 in Soft Tissue Sarcoma (ADCElerate 1)
EU CTIS ID: 2024-516900-41-00
What this study is testing
Phase 1a (Dose Escalation) and Phase 1b (Dose Confirmation): To determine the MTD/maximum administered dose and RP2DS of ADCE-D01; To assess the safety and tolerability of ADCE-D01. Phase 2 (Expansion Cohorts): To evaluate the antitumor activity of ADCE-D01 at the RP2DS; To further characterize the safety and tolerability of ADCE-D01 at the RP2DS.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Phase 1 Inclusion Criteria: Eligible patients are adults who have selected subtypes of STS with metastatic and/or unresectable disease. Patients must meet all the following criteria to be eligible for the study: ≥ 18 years of age
- Life expectancy of at least 3 months.
- Resolution of any toxicities from prior treatment(s) to ≤ Grade 1 by NCI CTCAE v5.0 criteria, or toxicities must have resolved to baseline, prior to first dose of study treatment. Note: unresolved prior treatment-related Grade 2 alopecia, stable Grade 2 peripheral neuropathy, or endocrine disorder adequately managed with hormone replacement therapy (HRT) is allowed.
- A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate.
- A female patient is eligible if not pregnant, not breast feeding, and at least one of the following applies: • Not a woman of childbearing potential (WOCBP), or • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment.
- Willing and able to comply with scheduled visits and procedures, drug administration plan, laboratory tests, or other study procedures and study restrictions.
You likely can't join if
- Phase 1 Exclusion Criteria: Patients who meet any of the following criteria are not eligible for the study: Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest computed tomography (CT) scan at screening.
- Presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study.
- Known hypersensitivity to any component of the study medication, excipients, or comparative drugs (e.g., Chinese hamster ovaries, monoclonal antibodies, camptothecin derivatives).
- Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required. Screening of asymptomatic patients without history of CNS metastases is not required. Patients with previously treated brain metastases are eligible, provided they have not experienced a seizure, had no significant change in neurological status, and have not required steroids for management of brain metastases in the last 2 weeks prior to enrolment.
- Active known second malignancy with the exception of any of the following: • Adequately treated basal cell carcinoma, • Adequately treated Stage 1 cancer from which the patient is currently in remission and has been in remission for ≥ 2 years; • Low-risk prostate cancer with a Gleason score < 7 and a prostate-specific antigen level < 10 ng/mL; • Any other cancer from which the patient has been disease-free for ≥ 3 years. squamous cell carcinoma of the skin, or in situ cervical cancer;
See the full eligibility criteria
Who can join
- Phase 1 Inclusion Criteria: Eligible patients are adults who have selected subtypes of STS with metastatic and/or unresectable disease. Patients must meet all the following criteria to be eligible for the study: ≥ 18 years of age
- Life expectancy of at least 3 months.
- Resolution of any toxicities from prior treatment(s) to ≤ Grade 1 by NCI CTCAE v5.0 criteria, or toxicities must have resolved to baseline, prior to first dose of study treatment. Note: unresolved prior treatment-related Grade 2 alopecia, stable Grade 2 peripheral neuropathy, or endocrine disorder adequately managed with hormone replacement therapy (HRT) is allowed.
- A male patient must agree to use barrier contraception during the treatment period and for at least 4 months after the last infusion of study treatment, and refrain from donating sperm during this period. Male patients with a pregnant partner must practice sexual abstinence or use a barrier method of contraception (e.g., condom) to prevent exposure of the fetus or neonate.
- A female patient is eligible if not pregnant, not breast feeding, and at least one of the following applies: • Not a woman of childbearing potential (WOCBP), or • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 7 months after last infusion of study treatment.
- Willing and able to comply with scheduled visits and procedures, drug administration plan, laboratory tests, or other study procedures and study restrictions.
- Phase 2 Inclusion Criteria: For Phase 2, the inclusion criteria will be amended based on emerging Phase 1 clinical data and the STS subtypes chosen for the Phase 2 expansion cohorts, as part of a substantial protocol amendment.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Histologically confirmed STS with metastatic and/or unresectable disease (not amenable to treatment with curative intent).
- Prior treatment with at least one but no more than two lines of systemic chemotherapy for metastatic/unresectable disease. Prior treatment must include an anthracycline (unless contraindicated or considered unsuitable for treatment with anthracycline). Patients may have received any number of systemic non-cytotoxic therapies. Prior systemic chemotherapy for STS given in a neoadjuvant or adjuvant setting will be considered as one line of therapy if radiological progression occurred either during that treatment or within 3 months of completion, otherwise it will not be counted as a line of treatment. Patient eligibility and appropriateness of study treatment must be discussed within the locally responsible medical team, to ensure that patients have had access to all approved and relevant standard of care treatments from which they are reasonably likely to have derived benefit.
- Progressive disease as per Investigator assessment.
- At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Availability of tumor tissue at screening. Either: a. An available tumor sample taken within 12 months prior to study entry, from either the primary tumor or metastatic site of disease, or b. A fresh biopsy from a tumor lesion(s) or metastases amenable to biopsy, as confirmed by a radiologist, if appropriate, and as deemed safe by the investigator.
- Hematological and biochemical parameters within the following ranges: Hb ≥ 9.0 g/dL; ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Total bilirubin ≤ 1.5 × ULN If known Gilbert syndrome: ≤ 3 × ULN; ALT and AST ≤ 2.5 × ULN or ≤ 5 × ULN if raised due to liver metastases Renal function – eGFR by CKD-EPI (2021) ≥ 60 mL/min; Coagulation – PT (or INR) ≤ 1.5 × ULN (if not on anticoagulants). If receiving anticoagulants, the value must be within the therapeutic range for the condition anticoagulated for; Potassium and corrected calcium - Within normal institutional limits
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
What rules you out
- Phase 1 Exclusion Criteria: Patients who meet any of the following criteria are not eligible for the study: Patients who have had systemic anticancer therapy, including any investigational agent within 4 weeks or 5 half-lives (whichever is shorter) prior to study treatment administration.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest computed tomography (CT) scan at screening.
- Presence of a medical or psychiatric condition that, in the opinion of the Principal Investigator, makes the patient inappropriate for inclusion in this study.
- Known hypersensitivity to any component of the study medication, excipients, or comparative drugs (e.g., Chinese hamster ovaries, monoclonal antibodies, camptothecin derivatives).
- Primary brain malignancy or known, untreated central nervous system (CNS) or leptomeningeal metastases, or symptoms suggesting CNS involvement for which treatment is required. Screening of asymptomatic patients without history of CNS metastases is not required. Patients with previously treated brain metastases are eligible, provided they have not experienced a seizure, had no significant change in neurological status, and have not required steroids for management of brain metastases in the last 2 weeks prior to enrolment.
- Active known second malignancy with the exception of any of the following: • Adequately treated basal cell carcinoma, • Adequately treated Stage 1 cancer from which the patient is currently in remission and has been in remission for ≥ 2 years; • Low-risk prostate cancer with a Gleason score < 7 and a prostate-specific antigen level < 10 ng/mL; • Any other cancer from which the patient has been disease-free for ≥ 3 years. squamous cell carcinoma of the skin, or in situ cervical cancer;
- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment administration, or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device or minor surgery is permitted prior to study treatment administration provided that the wound has healed.
- Ongoing systemic infection requiring treatment with antibiotic, antiviral, or antifungal treatment. Note: prophylactic treatment is allowed.
- Clinically significant cardiovascular disease, defined as any of the following: • Major electrocardiogram (ECG) abnormalities (e.g., symptomatic or sustained atrial or ventricular arrhythmias, second- or third-degree atrioventricular block, clinically significant bundle branch blocks, clinically significant ventricular hypertrophy); • Mean QTc interval value corrected by Fridericia’s formula for heart rate, (QTcF) > 470 msec measured on triplicate ECG; • Major abnormalities documented by echocardiogram (ECHO) (for example, moderate or severe heart valve function defect and/or left ventricular ejection fraction < 50%); • Unstable angina (anginal symptoms at rest) or new-onset angina within the last 3 months or myocardial infarction within the past 6 months; • Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg, which has been confirmed by 2 successive measurements despite optimal medical management; • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 3 months before study treatment administration (except for adequately treated catheter-related venous thrombosis occurring > 1 month prior to study treatment administration).
- Patients with acute infection with human immunodeficiency virus (HIV) 1 or HIV 2. Note: Patients with chronic HIV infection will be eligible if they are considered upon mutual agreement of the investigator and the Sponsor as safe for enrollment and are on an established antiretroviral therapy for at least 28 days and have CD4+ T-cell counts ≥ 350 cells/μL and HIV viral load < 400 copies/mL.
- Current active liver disease due to hepatitis B (hepatitis B virus [HBV] surface antigen positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV RNA). Patients with HCV with undetectable virus after treatment are eligible. Patients with a prior history of HBV are eligible if quantitative polymerase chain reaction (qPCR) for HBV DNA is negative.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.