Phase I/II study of ANV600 single agent or in combination with pembrolizumab in participants with advanced solid tumors (EXPAND-1)

Phase 1

Conditions: Advanced solid tumours
MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-509633-39-00

Lead Sponsor: Anaveon AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial;, 10. Female participants who are not postmenopausal, and who have not undergone surgical sterilization, must agree to use highly effective methods of contraception during the treatment period and for 6 months after the last dose of study treatment. They must also agree not to donate eggs (ova, oocytes) during the same timeframe;, 11. Male participants with partners of childbearing potential must agree to use highly effective methods of contraception and barrier contraception (condom) during the treatment period and for 6 months after the last dose of study treatment. They must also agree not to donate sperm during the same timeframe., 2. Life-expectancy = 3 months;, 3. Must be able to comply with the Protocol as judged by the Investigator;, 4. Be = 18 years of age on day of signing informed consent;, 5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;, 6. Have measurable disease per RECIST v1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions;, 7. Phase I : Participants with advanced unresectable or metastatic solid tumors for which no standard of care treatments are available, or participants who cannot tolerate such treatment. Phase II: Additional cohort specific criteria apply;, 8. Have adequate organ function as defined in the protocol;, 9. Negative serum pregnancy test within 7 days prior to the first dose of study treatment in women of childbearing potential and women <12 months after menopause;

Exclusion Criteria

1. For Phase I: Participants with pancreatic cancer (e.g. PDAC) or primary or secondary adrenal insufficiency;, 18. Have uncontrolled hepatitis B infection or hepatitis C infection;, 19. Have a history of an acute coronary event (e.g., myocardial infarction) within 3 months prior to study Day 1, uncontrolled and symptomatic coronary artery disease, or congestive heart failure NYHA Class III/IV;, 2. For Phase II: Participants with uveal and mucosal melanoma, and participants with primary tumor site of nasopharynx;, 20. Have an average QTcF interval >470 msec at screening;, 21. Have received a live vaccine, live-attenuated vaccine, mRNA-Based or Virus-Vectored vaccines within 30 days of study Day 1;, 22. Have a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study;, 23. Have a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator;, 24. Are pregnant, breastfeeding or expecting to conceive or father children during the study, from the screening visit through 6 months after the last dose of study treatment., 3. History of allergic reactions attributed to any of the excipients of ANV600, such as sucrose, histidine or polysorbate 80. For combination only: Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients;, 4. Have received investigational agent (including investigational device) within 4 weeks or an interval of five half-lives of the respective investigational agent prior to study Day 1; whichever is shorter;, 10. Have a known additional malignancy that is progressing or has required active treatment within the past 3 years;, 5. Have received IL-2 or IL-2 analogues as anti-cancer therapy within 18 months prior to study Day 1 (except IL-2 given in combination with cell therapy [e.g. TILs]);, 6. Have not recovered (i.e., = Grade 1 at baseline) from AEs resulting from prior immunotherapies with the following exceptions: a. Autoimmune AEs controlled by replacement therapy (e.g., hypothyroidism, adrenal insufficiency) b. Vitiligo or alopecia c. Psoriasis;, 7. Have received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to treatment;, 8. For combination only: Have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE;, 9. Have known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;, 25. Are deprived of liberty by judicial or administrative decision and/or subject to a legal protection measure (