Informations générales (source: ClinicalTrials.gov)
A Phase 1, Multicenter, Nonrandomized, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of YL201 in Patients With Advanced Solid Tumors
Interventional
Phase 1
MediLink Therapeutics (Suzhou) Co., Ltd. (Voir sur ClinicalTrials)
mai 2022
octobre 2027
05 décembre 2024
This is a phase 1, multicenter, nonrandomized, open-label, first-in-human study of YL201
conducted in China and the United States. The study will include 2 parts: a dose
escalation part (Part 1) followed by a dose expansion part (Part 2).
Part 1 will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced
solid tumors unresponsive to currently available therapies or for whom no standard
therapy is available.
Part 2 will include patients with selected advanced solid tumor types enrolled at the
MTD/RED(s), to better define the safety profile and evaluate the efficacy of YL201.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Study Coordinator | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Study Coordinator | 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 | |||||
| APHM - Hopital Nord - 13915 - Marseille - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre Georges-Francois Leclerc - 21000 - Dijon - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux - Hopital Saint Andre - 33000 - Bordeaux - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| CHU de Nantes - 44093 - Nantes - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - 86000 - Poitiers - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Institut de cancerologie de l'Ouest - Site Saint Herblain - 44800 - Saint-Herblain - France | Study Coordinator | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
Common Inclusion Criteria (Part 1 and Part 2)
- Informed of the trial before the start of the trial and voluntarily sign their name
and date on the ICF
- Aged ≥18 years
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Adequate organ and bone marrow function
- Female patients of childbearing potential must agree to use a highly effective form
of contraception and not donate, or retrieve for their own use, ova from the time of
screening and throughout the study period, and for at least 6 months after the last
dose of study drug. Male patients must agree to use a highly effective form of
contraception and not freeze or donate sperm from the time of screening and
throughout the study period, and for at least 6 months after the last dose of study
drug
- Life expectancy of ≥3 months
- Able and willing to comply with protocol visits and procedures
- Pathologically confirmed diagnosis of an advanced solid tumor for which prior
standard treatment had proven to be ineffective or intolerable, or no standard
treatment is available
Additional Inclusion Criteria for Part 1
- Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in
Solid Tumors (RECIST) version 1.1. Participants with prostate cancer who have bone
only disease may be eligible on a case-by-case basis after discussion with the
sponsor
Additional Inclusion Criteria for Part 2
- Have at least 1 measurable tumor lesion according to RECIST version 1.1.
Participants with prostate cancer who have bone only disease may be eligible on a
case-by-case basis after discussion with the sponsor
- Willing to provide archival or fresh tumor tissue samples. Patients who are not able
to provide tumor samples or have inadequate samples may be eligible on a
case-by-case basis after discussion with the sponsor
Common Inclusion Criteria (Part 1 and Part 2)
- Informed of the trial before the start of the trial and voluntarily sign their name
and date on the ICF
- Aged ≥18 years
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Adequate organ and bone marrow function
- Female patients of childbearing potential must agree to use a highly effective form
of contraception and not donate, or retrieve for their own use, ova from the time of
screening and throughout the study period, and for at least 6 months after the last
dose of study drug. Male patients must agree to use a highly effective form of
contraception and not freeze or donate sperm from the time of screening and
throughout the study period, and for at least 6 months after the last dose of study
drug
- Life expectancy of ≥3 months
- Able and willing to comply with protocol visits and procedures
- Pathologically confirmed diagnosis of an advanced solid tumor for which prior
standard treatment had proven to be ineffective or intolerable, or no standard
treatment is available
Additional Inclusion Criteria for Part 1
- Have at least 1 evaluable tumor lesion according to Response Evaluation Criteria in
Solid Tumors (RECIST) version 1.1. Participants with prostate cancer who have bone
only disease may be eligible on a case-by-case basis after discussion with the
sponsor
Additional Inclusion Criteria for Part 2
- Have at least 1 measurable tumor lesion according to RECIST version 1.1.
Participants with prostate cancer who have bone only disease may be eligible on a
case-by-case basis after discussion with the sponsor
- Willing to provide archival or fresh tumor tissue samples. Patients who are not able
to provide tumor samples or have inadequate samples may be eligible on a
case-by-case basis after discussion with the sponsor
Common Exclusion Criteria (Part 1 and Part 2)
- Intolerant to prior treatment with a topoisomerase I inhibitor or an ADC that
consists of a topoisomerase I inhibitor, including but not limited to topotecan,
irinotecan, and Dxd
- Concurrent enrollment in another clinical study, unless it is an observational
(noninterventional) clinical study or during the follow-up period of an
interventional study
- Prior systemic anticancer treatment including chemotherapy, molecular targeted
therapy, hormonal therapy, immunotherapy, or biological therapy within 3 weeks
before the first dose of study drug (use of oral fluorouracil [eg, tegafur and
capecitabine] or small molecular targeted therapy within 2 weeks or 5 half-life
periods [whichever is shorter] before the first dose; use of mitomycin or
nitrosoureas within 6 weeks before the first dose; use of herbal medicine with
antitumor indications or nonspecific immunomodulators [eg, thymosin, interferon, and
interleukin] within 2 weeks before the first dose)
- Prior radiation therapy, including palliative stereotactic radiation with abdominal,
within 4 weeks before the first dose of study drug (if palliative stereotactic
radiation therapy without abdominal, within 2 weeks)
- Undergone major surgery (not including diagnostic surgery) within 4 weeks before the
first dose of study drug or expect major surgery during the study
- Undergone allogeneic hematopoietic stem cell transplantation (HSCT) before the first
dose of study drug, or autologous HSCT within 3 months before the first dose of
study drug
- Received systemic steroids (>10 mg/day of prednisone or its equivalent) or other
immunosuppressive therapy within 2 weeks before the first dose of study drug. The
following are exceptions to this criterion:
1. Intranasal, inhaled, topical steroids, or local steroid injections (eg,
intra-articular injection)
2. Systemic steroids at physiological doses as replacement therapy (eg,
physiological corticosteroid replacement therapy for adrenal or pituitary
insufficiency)
3. Steroids as premedication for hypersensitivity reactions (eg, CT scan
premedication)
- Received any live vaccine within 4 weeks before the first dose of study drug or
intend to receive a live vaccine during the study
- A history of leptomeningeal carcinomatosis
- Brain metastases or spinal cord compression unless asymptomatic or treated and
stable off steroids and anti-convulsants for at least 2 weeks before the first dose
of study drug
- Uncontrolled or clinically significant cardiovascular disease
- A history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that
requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis
cannot be ruled out by imaging at screening
- Clinically significant concomitant pulmonary disease
- Have a diagnosis of Gilbert's syndrome
- Uncontrolled third-space fluid that requires repeated drainage
- Active gastric and duodenal ulcers, ulcerative colitis, or other gastrointestinal
conditions that may cause bleeding or perforation by the investigator's discretion
- Uncontrolled infection that requires systemic therapy within 1 week before the first
dose
- Known human immunodeficiency virus (HIV) infection
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Active HBV is
defined as hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg)
positive, and HBV DNA level above ULN at the study site; active HCV is defined as
positive hepatitis C antibody and HCV RNA level above ULN at the study site
- Unresolved toxicities from previous anticancer therapy, defined as toxicities not
yet resolved to NCI CTCAE Grade ≤1, baseline, or the level specified in the
inclusion/exclusion criteria with the exception of alopecia (any grade),
pigmentation (any grade), and peripheral neuropathy (Grade ≤2). Patients with
irreversible toxicity (eg, hearing loss) that is reasonably not expected to be
aggravated by the study drug can be enrolled after discussion with the sponsor
- A history of severe hypersensitivity reactions to the drug substances, inactive
ingredients in the drug product, or other mAbs
- Women who are breastfeeding or pregnant as confirmed by pregnancy tests performed
within 7 days before the first dose
- Any illness, medical condition, organ system dysfunction, or social situation,
including but not limited to mental illness or substance/alcohol abuse, deemed by
the investigator to be likely to interfere with a patient's ability to sign informed
consent, adversely affect the patient's ability to cooperate and participate in the
study, or compromise the interpretation of study results Additional Exclusion
Criteria for Part 2
- Multiple primary malignancies within 3 years, except adequately resected
non-melanoma skin cancer, curatively treated in situ disease, or other curatively
treated solid tumors