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New treatment option for Ovarian Cancer
Official title Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors
ClinicalTrials.gov ID: NCT05797168
What this study is testing
What is Torvutatug samrotecan?
Torvutatug samrotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovarian cancer.
Also referred to as Torvu-sam, AZD5335.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130
You may be able to join if
- Core
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic...
- Participant must be ≥ 18 years at the time of signing the informed consent.
- Willing to provide adequate archival and/or baseline tumor sample as applicable per module-specific criteria.
You likely can't join if
- Patients with spinal cord compression or a history of leptomeningeal carcinomatosis.
- Patients with brain metastases unless, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or...
- Treatment with any of the protocol defined medications, without adequate washout periods or time before the first dose of study intervention.
- Unresolved toxicities of Grade ≥ 2 (National Cancer Institute [NCI] CTCAE v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine...
- Active infection, including tuberculosis and infections with hepatitis B virus (HBV; verified by known positive hepatitis B surface antigen [HBsAg]...
- Negative for HBsAg and positive for anti-hepatitis B virus core protein (HBc) or
See the full eligibility criteria
Who can join
- Core
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Participants who do not provide...
- Participant must be ≥ 18 years at the time of signing the informed consent.
- Willing to provide adequate archival and/or baseline tumor sample as applicable per module-specific criteria.
- For participants who have previously received targeted therapies such as ADCs, a fresh baseline biopsy will be required unless the most recent archival tissue sample was collected after receipt of such treatment.
- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical trial is...
- Participants must have measurable disease per RECIST v1.1,
- A previously irradiated lesion can be considered a target lesion if the lesion is progressing and well defined.
- For participants who undergo biopsies at screening and/or on treatment, it is preferred though not required, that the biopsied lesion, be distinct from any target lesion used in the RECIST v1.1 evaluation.
- Life expectancy ≥ 12 weeks.
- Adequate organ and marrow function.
- Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. (a) Male participants: (i) Male participants who are...
What rules you out
- Patients with spinal cord compression or a history of leptomeningeal carcinomatosis.
- Patients with brain metastases unless, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to first dose of study intervention.
- Treatment with any of the protocol defined medications, without adequate washout periods or time before the first dose of study intervention.
- Unresolved toxicities of Grade ≥ 2 (National Cancer Institute [NCI] CTCAE v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy)...
- Active infection, including tuberculosis and infections with hepatitis B virus (HBV; verified by known positive hepatitis B surface antigen [HBsAg] result), hepatitis C virus (HCV) or known HIV infection that is not...
- Negative for HBsAg and positive for anti-hepatitis B virus core protein (HBc) or
- Are HBsAg + with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below: (i) HBV DNA viral load \<100 IU/mL. (ii) Have normal transaminase values, or, if liver metastases are present...
- Patient has active ILD/pneumonitis or has a history of (non-infectious) ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at...
- Patients with a history of radiation pneumonitis which has clinically and radiologically resolved and not requiring treatment with steroids may be eligible.
- History of another malignancy except for:
- Malignancy treated with curative intent and with no known active disease for at least 2 years prior to screening of study intervention and with low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Localized non-invasive solid organ primary disease under surveillance.
- Patients with any of the following cardiac criteria:
- History of arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, and ventricular tachycardia), which is symptomatic or requires treatment NCI CTCAE v5.0 Grade 3 except for: (i) Rate...
- NOTE: significant abnormalities in serum electrolytes that can increase the risk of arrhythmic events (ie, sodium, potassium, calcium, and magnesium) should be corrected before starting the study intervention.
- Uncontrolled hypertension.
- Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months of screening.
- History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening.
- Symptomatic heart failure (as defined by New York Heart Association class ≥ 2).
- Prior or current diagnosis of cardiomyopathy considered clinically relevant per investigator's judgement.
- Severe uncorrected valvular heart disease.
- Mean resting QTcF \> 470 msec obtained from triplicate electrocardiograms (ECGs) and averaged, recorded within 5 minutes.
- Any factor that, in the opinion of the investigator, increases the proarrhythmic risk of QT prolongation, such as congenital long QT syndrome, family history of long QT syndrome, hypertrophic cardiomyopathy, or...
- Uncontrolled and/or unresolved intercurrent illness within 12 months prior to screening, including but not limited to serious chronic gastrointestinal conditions associated with diarrhea, or illness (including...
- Substance abuse or any other medical conditions that would increase the safety risk to the participant or interfere with participation of the participant or evaluation of the clinical study in the opinion of the...
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Participants, if enrolled, should not receive live vaccine whilst receiving study intervention and up to 3 months...
- For women only - currently pregnant (confirmed with positive pregnancy test or suspected), lactating, breastfeeding, or intention to become pregnant during the study period.
- Concurrent enrolment in another clinical study, unless it is an observational (non treatment) clinical study or during the follow-up period of an treatment study. Exception: Diagnostic imaging evaluation studies (e.g...
- Patients with a known hypersensitivity to study intervention or any of the excipients of the product.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
- Previous enrolment in the present study. \ \ Other module specific criteria may apply
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Aurora, Colorado, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Liverpool, Australia
- Melbourne, Australia
- Edmonton, Alberta, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Chengdu, China
- Chongqing, China
+ 31 more site(s).
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, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States; Aurora, Colorado, United States; Louisville, Kentucky, United States; Boston, Massachusetts, United States and 45 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.