A Modular Phase I/IIa, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Ascending Doses of AZD5335 Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors

Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:

• 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,

‣ 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 sexually active with a female partner of childbearing potential must use a male condom (plus an additional contraceptive method) post-screening through 5 months following the last dose of study intervention. It is strongly recommended for the female partner of a male participant to also use a highly effective method of contraception throughout this period. In addition, male participants must refrain from freezing or donating sperm while on study and for 5 months following the last dose of study intervention.

• (b) Female participants: (i) Females of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study intervention and a negative urine or serum pregnancy test prior to starting their next cycle of treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

∙ (ii) (ii) Sex and Contraceptive/Barrier Requirements: Highly effective birth control methods include: Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) \[(periodic abstinence e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception\], a vasectomized partner, Implanon®, bilateral tubal occlusion, intrauterine device/levonorgestrel intrauterine system, Depo Provera™ injections, oral contraceptive associated with inhibition of ovulation, and Evra Patch™, Xulane™, or NuvaRing®.

∙ Female participants of childbearing potential who are sexually active with a non-sterilized male partner must agree to use one highly effective method of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly), from enrolment throughout the study and for 8 months following the last dose of study intervention. The male partner of a female participant of childbearing potential must also use a male condom (plus spermicide, if available) throughout this period. Cessation of contraception after this point should be discussed with a responsible physician. In addition, female participants must not donate or retrieve for their own use, ova while on study and for 8 months following the last dose of study intervention.

Locations
United States
California
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RECRUITING
Duarte
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RECRUITING
Irvine
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WITHDRAWN
La Jolla
Colorado
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Aurora
Kentucky
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TERMINATED
Louisville
Massachusetts
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Boston
Michigan
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Detroit
Ohio
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Columbus
Oregon
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Portland
Rhode Island
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Providence
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Providence
Texas
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Houston
Virginia
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Fairfax
Other Locations
Australia
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Liverpool
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Melbourne
Canada
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Edmonton
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London
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Montreal
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Montreal
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Toronto
China
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Chengdu
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Chongqing
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Guangzhou
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Guangzhou
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Jinan
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Xi'an
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RECRUITING
Zhengzhou
Germany
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NOT_YET_RECRUITING
Berlin
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NOT_YET_RECRUITING
Essen
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NOT_YET_RECRUITING
Freiburg Im Breisgau
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RECRUITING
Hanover
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NOT_YET_RECRUITING
Leipzig
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RECRUITING
Mannheim
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Regensburg
Israel
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Haifa
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Ramat Gan
Japan
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Hidaka-shi
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Kashiwa
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Kōtoku
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Sunto-gun
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Tokyo
Republic of Korea
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Seoul
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Seoul
Spain
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Barcelona
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Madrid
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Madrid
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Málaga
Taiwan
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Taichung
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Tainan
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Taipei
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Taipei
Turkey
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Ankara
Research Site
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Ankara
Research Site
RECRUITING
Ankara
Research Site
RECRUITING
Istanbul
United Kingdom
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RECRUITING
Cambridge
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Glasgow, Scotland
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NOT_YET_RECRUITING
London
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RECRUITING
London
Research Site
RECRUITING
Sutton
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2023-06-05
Estimated Completion Date: 2028-01-06
Participants
Target number of participants: 506
Treatments
Experimental: Module 1: AZD5335 Monotherapy
AZD5335 Monotherapy
Experimental: Module 2: AZD5335 + Saruparib
AZD5335 + Saruparib
Experimental: Module 3: AZD5335 + Bevacizumab
AZD5335 + Bevacizumab
Experimental: Module 4: AZD5335 + Carboplatin +/- Bevacizumab
AZD5335 + Carboplatin +/- Bevacizumab
Experimental: Module 5: AZD5335 + AZD9574
AZD5335 + AZD9574
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov