Informations générales (source: ClinicalTrials.gov)
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Interventional
Phase 1
Amgen (Voir sur ClinicalTrials)
mars 2024
décembre 2028
06 juin 2025
The primary objectives of this study are to:
- Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination
with pembrolizumab in participants with advanced solid tumors
- Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as
monotherapy and in combination with pembrolizumab in participants with advanced
solid tumors.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Bergonie - 33076 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Age ≥ 18 years at the time of signing informed consent.
- Participants with histologically or cytologically confirmed metastatic or locally
advanced solid tumors who have relapsed after and/or are refractory to or ineligible
for established and available therapies with known clinical benefit at time of
pre-screening:
- Group A: NSCLC, CRC, GC, and melanoma.
- Group B: NSCLC, CRC, GC.
- Eastern Cooperative Oncology Group Performance status 0 or 1.
- Life expectancy of > 3 months, in the opinion of the investigator.
- At least 1 measurable lesion as defined by modified RECIST 1.1 guidelines. Note:
this lesion should be avoided for the required biopsies on the study.
- Participants must be willing to undergo 1 or more biopsies as follows:
- Fresh biopsy prior to enrollment is preferred or, if fresh tissue is not
obtainable, an archival tumor sample may be acceptable if the sample was
obtained within 6 months of enrollment and participant has not received any
other treatment since sample was obtained, consult the Medical Monitor.
- Mandatory fresh biopsy during cycle 2 (before the restaging of CT-scan) of
treatment with AMG 355 (± pembrolizumab).
Note: Where slides are accepted, samples must consist of a minimum of 11 (21 preferred)
freshly-cut, serially, sectioned, unstained slides. A formalin-fixed, paraffin embedded
block is preferred if available, but in lieu of a block, unstained slides or fresh wet
tissue is acceptable.
Key
- Age ≥ 18 years at the time of signing informed consent.
- Participants with histologically or cytologically confirmed metastatic or locally
advanced solid tumors who have relapsed after and/or are refractory to or ineligible
for established and available therapies with known clinical benefit at time of
pre-screening:
- Group A: NSCLC, CRC, GC, and melanoma.
- Group B: NSCLC, CRC, GC.
- Eastern Cooperative Oncology Group Performance status 0 or 1.
- Life expectancy of > 3 months, in the opinion of the investigator.
- At least 1 measurable lesion as defined by modified RECIST 1.1 guidelines. Note:
this lesion should be avoided for the required biopsies on the study.
- Participants must be willing to undergo 1 or more biopsies as follows:
- Fresh biopsy prior to enrollment is preferred or, if fresh tissue is not
obtainable, an archival tumor sample may be acceptable if the sample was
obtained within 6 months of enrollment and participant has not received any
other treatment since sample was obtained, consult the Medical Monitor.
- Mandatory fresh biopsy during cycle 2 (before the restaging of CT-scan) of
treatment with AMG 355 (± pembrolizumab).
Note: Where slides are accepted, samples must consist of a minimum of 11 (21 preferred)
freshly-cut, serially, sectioned, unstained slides. A formalin-fixed, paraffin embedded
block is preferred if available, but in lieu of a block, unstained slides or fresh wet
tissue is acceptable.
Key
- Participant who 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 (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137),
and was discontinued from that treatment due to an immune-related adverse events.
- Untreated or symptomatic brain metastases and leptomeningeal disease Note:
participants with previously treated brain metastases may participate provided they
are radiologically stable, ie, 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.
- Chronic intake of systemic corticosteroids (eg prednisone > 10 mg/day or equivalent)
or any other form of immunosuppressive therapy within 7 days prior to the first dose
of study treatment.
- Has an active autoimmune disease that has required systemic treatment in past 2
years (ie, with use of disease modifying agents, corticosteroids, or
immunosuppressive drugs). Replacement therapy (eg, thyroxine or insulin) is not
considered a form of systemic treatment and is allowed.
- History of organ transplantation.
- History of (non-infectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
- History of any immune-related colitis. Infectious colitis is allowed if evidence of
adequate treatment and clinical recovery exists and at least 3 months interval
observed since diagnosis of colitis.
Other protocol-defined inclusion/exclusion criteria apply.