Phase I/IIa Study of AZD5335 for Solid Tumors
This study is testing a new treatment called AZD5335, which is an antibody-drug conjugate (a type of targeted chemotherapy that delivers a drug directly to cancer cells). It will be given either alone or with other anti-cancer drugs like Torvutatug samrotecan, Saruparib, Bevacizumab, Carboplatin, or Palacaparib. This research aims to see if these treatments are safe, tolerable, and effective against advanced solid tumors, including ovarian, lung adenocarcinoma, endometrial, and lung squamous cell cancers. You may be able to join if you are 18 years or older and can provide informed consent. The study will measure side effects and how many participants experience dose-limiting toxicities (serious side effects that prevent further treatment). The current recruitment status is unclear.
- Study design
- This is a Phase I/IIa, modular, open-label (meaning you and your doctors will know what treatment you are receiving), multi-center study. It plans to enroll 602 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from the time you give consent until 30 days after your last dose of treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05797168
Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentAstraZeneca
~602 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Torvutatug samrotecanSaruparibBevacizumabCarboplatinPalacaparibPembrolizumab
At a glance
Recruiting sites
55 of 60 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events/serious adverse events
Measured over From time of Informed Consent to 30 days post last dose.
+1 more outcome measured
Conditions
Where it's being run
60 sites across 23 statesChina7
Germany7
Japan5
United Kingdom5
Spain4
Taiwan4
Turkey (Türkiye)4
California3
Study leadership
- Funda Meric-Bernstam, MD · PRINCIPAL_INVESTIGATOR · UT MD Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 informed consent for Optional Genetic Research may still be enrolled in the study.
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 the best option for the next treatment based on response and/or tolerability to prior therapy. Participants with contraindications or who refuse therapy in accordance with local practice may also be considered provided that it is documented that he/she was informed about all therapeutic options.
Participants must have measurable disease per RECIST v1.1,
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.
Exclusion
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). Participants with stable ≤ Grade 2 neuropathy are eligible.
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 well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count ≥ 350/mm3, no history of acquired immune deficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen).
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 screening.
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:
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 unexplained sudden cardiac death under 40 years of age.
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 psychiatric illness) and/or social situations, in the opinion of the investigator, that would limit compliance with study requirements and activities, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.
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 Investigator.
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 after the last dose of study intervention. Participants can receive Coronavirus (COVID)-19 vaccines, at the discretion of the Investigator, following a benefit/risk evaluation for the individual participant and in accordance with local rules and regulations and vaccination guidelines. Note: If a COVID-19 vaccine is administered it should be done \> 72 hours prior to study intervention initiation or after completion of the DLT period.
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 interventional) clinical study or during the follow-up period of an interventional study. Exception: Diagnostic imaging evaluation studies (e.g. PET) may be allowed subject to case-by-case discussion with the Sponsor.
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
What this trial measures
- Number of participants with adverse events/serious adverse eventsFrom time of Informed Consent to 30 days post last dose.
Number of participants with incidence of adverse events and with serious adverse events including changes from baseline in laboratory parameters, vital signs, ECGs, and physical examination.
- The number of participants with dose limiting toxicity(DLT), as defined in the protocolFrom the first dose of torvu-sam on Cycle 1 Day 1 up to and including the planned end of Cycle 1 (At the end of 21 days)
A DLT is defined as any ≥ Grade 3 treatment-emergent AE that occurs during the DLT evaluation period, not attributable to the underlying disease or extraneous causes (as defined in the protocol)