Informations générales (source: ClinicalTrials.gov)
A Multicenter Phase 1, Open-Label Study of NB003 to Assess Safety, Tolerability, Pharmacokinetics and Efficacy in Patients With Advanced Malignancies
Interventional
Phase 1
Ningbo Newbay Technology Development Co., Ltd (Voir sur ClinicalTrials)
août 2021
décembre 2025
24 mai 2025
This a A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and
Pharmacokinetics of NB003 in Subjects with Advanced Malignancies
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Rastilav BAHLEDA | 12/06/2024 09:14:07 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - 69373 - Lyon cedex 08 - Rhone - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Males or females of any race ≥18 years age.
2. Histologically-confirmed diagnosis of unresectable, relapsed or metastatic GIST or
other advanced malignancies.
1. For dose escalation phase:
- GIST patients must have progressed on or had an intolerability to imatinib
and other SoCs or refused other SoCs.
- Patients with an advanced solid tumor other than GIST must have relapsed
or had refractory disease without an available effective therapy and
harbor KIT or PDGFRα gene alterations (central laboratory confirmation is
not required for screening).
2. For dose expansion phase:
Cohort 1: GIST patients with KIT or PDGFRα gene mutations, must have progressed on
or been intolerant to at least imatinib, sunitinib, regorafenib and ripretinib (≥
fifth line therapy setting); Cohort 2a: GIST patients with KIT or PDGFRα gene
mutations, must have progressed on or been intolerant to imatinib and sunitinib, and
who have not received additional systemic therapy for advanced GIST (third line
therapy setting); Cohort 2b: GIST patients with KIT or PDGFRα gene mutations, must
have progressed on or been intolerant to imatinib, sunitinib and regorafenib, and
who have not received additional systemic therapy for advanced GIST (forth line
therapy setting); Cohort 3: GIST patients with KIT or PDGFRα gene mutations, must
have progressed on or been intolerant to imatinib and have not received additional
systemic therapy for advanced GIST (second line therapy setting); Cohort 4: GIST
patients with PDGFRα exon 18 mutation and must have progressed on or been intolerant
to avapritinib; in the countries/regions where avapritinib is not SoC,
avapritinib-naïve patients can be enrolled; Cohort 5: Unresectable or metastatic
melanoma patients with demonstrated evidence for KIT gene mutation and/or
amplification, must have progressed on or been intolerant to SoCs; Cohort 6:
Patients with other advanced malignancies other than GIST or melanoma which must be
relapsed or refractory without an available effective therapy and harbor KIT or
PDGFRα gene alterations.
3. For dose expansion phase: at least one measurable lesion per RECIST v1.1/mRECIST.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Life expectancy ≥ 12 weeks.
6. Adequate organ and marrow function.
7. Tumor sample collection is required.
1. Males or females of any race ≥18 years age.
2. Histologically-confirmed diagnosis of unresectable, relapsed or metastatic GIST or
other advanced malignancies.
1. For dose escalation phase:
- GIST patients must have progressed on or had an intolerability to imatinib
and other SoCs or refused other SoCs.
- Patients with an advanced solid tumor other than GIST must have relapsed
or had refractory disease without an available effective therapy and
harbor KIT or PDGFRα gene alterations (central laboratory confirmation is
not required for screening).
2. For dose expansion phase:
Cohort 1: GIST patients with KIT or PDGFRα gene mutations, must have progressed on
or been intolerant to at least imatinib, sunitinib, regorafenib and ripretinib (≥
fifth line therapy setting); Cohort 2a: GIST patients with KIT or PDGFRα gene
mutations, must have progressed on or been intolerant to imatinib and sunitinib, and
who have not received additional systemic therapy for advanced GIST (third line
therapy setting); Cohort 2b: GIST patients with KIT or PDGFRα gene mutations, must
have progressed on or been intolerant to imatinib, sunitinib and regorafenib, and
who have not received additional systemic therapy for advanced GIST (forth line
therapy setting); Cohort 3: GIST patients with KIT or PDGFRα gene mutations, must
have progressed on or been intolerant to imatinib and have not received additional
systemic therapy for advanced GIST (second line therapy setting); Cohort 4: GIST
patients with PDGFRα exon 18 mutation and must have progressed on or been intolerant
to avapritinib; in the countries/regions where avapritinib is not SoC,
avapritinib-naïve patients can be enrolled; Cohort 5: Unresectable or metastatic
melanoma patients with demonstrated evidence for KIT gene mutation and/or
amplification, must have progressed on or been intolerant to SoCs; Cohort 6:
Patients with other advanced malignancies other than GIST or melanoma which must be
relapsed or refractory without an available effective therapy and harbor KIT or
PDGFRα gene alterations.
3. For dose expansion phase: at least one measurable lesion per RECIST v1.1/mRECIST.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. Life expectancy ≥ 12 weeks.
6. Adequate organ and marrow function.
7. Tumor sample collection is required.
1. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is
longer, up to a maximum wash-out period of 21 days prior to the initiation of study
drug administration.
2. Major surgery within 4 weeks of the first dose.
3. Radiotherapy with a limited field of radiation for palliation within 1 week prior to
the first dose, with the exception as defined.
4. Patients currently receiving medications or herbal supplements known to be strong
inhibitors or inducers of CYP3A4.
5. Patients currently receiving acid-reducing agents and are unable to stop use at
least 2 weeks prior to the first dose.
6. Any known active central nervous system metastases and/or carcinomatous meningitis.
Active infection including hepatitis B, hepatitis C, and HIV.
7. Any other clinically significant comorbidities, such as uncontrolled pulmonary
disease, active infection, uncontrolled pericardial effusion, uncontrolled pleural
effusion, or any other conditions, which in the judgment of Investigator, could
compromise compliance with the protocol, interfere with the interpretation of study
results, or predispose the patient to safety risks.
8. Any evidence of severe or uncontrolled systemic diseases which in the Investigator's
opinion makes it undesirable for the patient to participate in the trial or which
would jeopardize compliance with the protocol.