Platform Study of AB122 Based Treatments in Patients with Advanced Solid Tumors

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.

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

• Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);

• Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;

• Has adequate organ function as defined by the following criteria:

‣ AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN

⁃ T-Bil of ≤ 1.5 × ULN

⁃ ANC ≥ 1500 /mm3 (ie, ≥ 1.5 × 109 /L by International System of Units \[SI\]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor \[G-CSF\])

⁃ Platelet count ≥ 100000 /mm3 (SI: ≥ 100 × 109 /L) (excluding measurements obtained within 7 days after a transfusion of platelets)

⁃ Hemoglobin value of ≥ 9.0 g/dL excluding measurements within 4 weeks after a transfusion of packed red blood cells (RBCs) or whole blood

• Has a life expectancy of at least 90 days;

∙ Cohort A-1 and A-2

• Japanese male and female;

• Has a histologically or cytologically confirmed diagnosis of solid tumor;

• Has disease progression after standard treatment for advanced or metastatic disease, are intolerant to the standard treatment;

∙ Cohort B-1

• Has a histologically or cytologically confirmed diagnosis of PDAC;

• Has disease progression after or intolerant to one prior systemic chemotherapy for advanced or metastatic disease

∙ Cohort B-2

• Has a histologically or cytologically confirmed diagnosis of CRC.

• Has been received one regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the chemotherapy

∙ Cohort B-3 - Has a histologically or cytologically confirmed non-squamous NSCLC;

• Has been received one or two regimen of standard chemotherapy for advanced or metastatic disease, and was refractory or intolerant to the standard treatment

• Has been most recently received regimen including an ICI (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies) and platinum-based chemotherapy in combination or in sequence (i.e., platinum-based chemotherapy followed by checkpoint inhibitor therapy), and all of the following criteria must be met:

‣ Received at least 2 doses at the most recent ICI therapy

⁃ Radiographic complete response or partial response based on investigator assessment with ICI therapy

⁃ Documented radiographic disease progression with above most recently received regimen

∙ Cohort C-1

• Has unresectable advanced or recurrent gastric cancer or gastroesophageal junction cancer as pathologically confirmed adenocarcinoma

• Gastroesophageal junction cancer is defined as a tumor with an epicenter that is located within 2 cm proximal to and distal from the esophagogastric junction (the boundary of esophageal and gastric muscularis).

• Has received 2-4 standard regimens listed below and has demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose (The patient is eligible if the treatment is discontinued owing to SAEs, allergic reactions, or neurotoxicities.):

‣ fluoropyrimidines and platinum

⁃ taxane or irinotecan

⁃ ramucirumab

∙ Cohort C-2

• Has histologically confirmed unresectable adenocarcinoma of the colon or rectum (all other histological types are excluded)

• RAS status must have been previously determined (mutant or wild-type) based on local assessment of tumor biopsy; Wild type is defined as v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) (exon 2, 3 and 4) and neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type. \[Mutant is defined as at least KRAS or NRAS mutant (any exon, any mutation)\].

• Has received at least 2 prior chemotherapy regimens for the treatment of advanced CRC and had demonstrated disease progression according to imaging test during the most recent treatment or within 12 weeks after the final dose , or intolerance to their last regimen, and all of the following criteria must be met:

‣ Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody

⁃ For RAS wild-type patients, an anti-EGFR monoclonal antibody must have included in addition to above

∙ Cohort D-1

• Has histologically confirmed advanced or metastatic NSCLC regardless of histologic type.

• Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory.

∙ Cohort D-2

• Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.

• No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.

∙ Cohort D-3

• Has histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus.

• No prior therapy for advanced or metastatic disease, or refractory or intolerant to at least 1 cycle of standard first-line therapy.

‣ Treatment discontinued due to intolerable toxicity or because the same drug cannot be re-treated before the disease progresses is considered as intolerable to the previous treatment.

⁃ Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.

∙ Cohort D-4

• Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).

‣ The confirmed status of the human papillomavirus (HPV) in cancers of the mid-pharynx.

⁃ Patient background such as combined positive score (CPS) and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.

• No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.

∙ Cohort D-5

• Has histologically or cytologically confirmed recurrent or advanced squamous head and neck cancer (oropharynx, oral mucosa, hypopharynx, larynx).

‣ The confirmed status of the HPV in cancers of the mid-pharynx.

⁃ Patient background such as CPS and head and neck cancer treatment guidelines must be taken into account to confirm the validity of enrollment in this cohort.

• No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy. • Treatment of locally advanced disease completed more than 6 months prior to the start of study drug administration is not considered prior therapy.

∙ Cohort D-6

• Has histologically or cytologically confirmed recurrent or advanced squamous NSCLC.

• No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.

∙ Cohort D-7

• Has histologically confirmed unresectable or advanced biliary tract cancer (intrahepatic bile duct, extrahepatic bile duct, gallbladder, or duodenal papillary region) with a diagnosis of adenocarcinoma or adenosquamous carcinoma.

• No prior therapy for advanced or metastatic disease. • Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.

∙ Cohort D-8

• Has histologically confirmed unresectable or advanced pancreatic ductal adenocarcinoma (highly differentiated, moderately differentiated, or poorly differentiated).

• No prior therapy for advanced or metastatic disease. Adjuvant therapy or neo adjuvant therapy is not considered as prior therapy if there is no recurrence during or within 6 months after completion of the therapy.

∙ Cohort E-1

• Has a histologically or cytologically confirmed advanced or metastatic NSCLC regardless of histologic type.

• Has PD-L1 (≥ 50% tumor proportion score) in tumor tissue sample as determined at a local laboratory (except for tolerability part).

• Has been received 1-4 regimen for advanced or metastatic disease

• Has been received one regimen of ICI monotherapy or combination therapy (anti PD-1 antibodies, anti PD-L1 antibodies or anti CTLA-4 antibodies), and all of the following criteria must be met:

‣ Received at least 2 doses of the ICI therapy

⁃ Documented radiographic disease progression with or after ICI therapy

∙ Cohort E-2

• Has a histologically or cytologically confirmed advanced or metastatic ASPS

• Is male or female aged ≥ 16 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedure

Locations
Other Locations
Japan
A site selected by Taiho Pharmaceutical Co., Ltd.
RECRUITING
Aichi
A site selected by Taiho Pharmaceutical Co., Ltd.
RECRUITING
Chiba
A site selected by Taiho Pharmaceutical Co., Ltd.
RECRUITING
Ehime
A site selected by Taiho Pharmaceutical Co., Ltd.
RECRUITING
Hokkaido
A site selected by Taiho Pharmaceutical Co., Ltd.
RECRUITING
Kanagawa
A site selected by Taiho Pharmaceutical Co., Ltd.
RECRUITING
Osaka
A site selected by Taiho Pharmaceutical Co., Ltd.
RECRUITING
Shizuoka
A site selected by Taiho Pharmaceutical Co., Ltd.
RECRUITING
Tokyo
A site selected by Taiho Pharmaceutical Co., Ltd.
RECRUITING
Wakayama
Contact Information
Primary
Drug Information Center
toiawase@taiho.co.jp
+81-3-3294-4527
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2026-05
Participants
Target number of participants: 917
Treatments
Experimental: Cohort A-1
AB122 will be given in participants with advanced or metastatic solid tumor.
Experimental: Cohort A-2
AB122 will be given in participants with advanced or metastatic solid tumor.
Experimental: Cohort B-1
AB122 will be given in combination with TAS-116 in participants with pancreatic ductal adenocarcinoma.
Experimental: Cohort B-2
AB122 will be given in combination with TAS-116 in participants with unresectable metastatic MSS/pMMR CRC without liver metastases.
Experimental: Cohort B-3
AB122 will be given in combination with TAS-116 in participants with unresectable metastatic non-squamous NSCLC without actionable gene alterations.
Experimental: Cohort D-1
AB122 will be given in combination with TAS-120 in participants with unresectable metastatic NSCLC with PD-L1 high expression and without actionable gene alterations.
Experimental: Cohort E-1
AB122 will be given in combination with TAS-115 in participants with unresectable metastatic NSCLC without actionable gene alterations.
Experimental: Cohort E-2
AB122 will be given in combination with TAS-115 in participants with unresectable metastatic ASPS, in those who received or no prior regimen for advanced disease.
Experimental: Cohort C-1
AB122 will be given in combination with TAS-102 and Ramucirumab in participants with unresectable or recurrent gastric cancer or gastroesophageal junction cancer.
Experimental: Cohort C-2
AB122 will be given in combination with TAS-102 and Bevacizumab in participants with unresectable metastatic CRC.
Experimental: Cohort D-2
AB122 will be given in combination with TAS-120, Fluorouracil and Cisplatin in participants with histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus with no prior treatment for advanced cancer.
Experimental: Cohort D-3
AB122 will be given in combination with TAS-120 and AB154 in participants with histologically diagnosed advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus with no prior treatment for advanced cancer or who have been previously treated with one line of chemotherapy.
Experimental: Cohort D-4
AB122 will be given in combination with TAS-120, Fluorouracil and Cisplatin/Carboplatin in participants with histologically diagnosed advanced or metastatic squamous cell carcinoma of the head and neck (middle pharynx, oral cavity, hypopharynx, larynx) with no prior treatment for advanced cancer.~・The validity of enrollment in the cohort must be confirmed, taking into account the patient background including CPS and the guidelines for head and neck cancer treatment.
Experimental: Cohort D-5
AB122 will be given in combination with TAS-120 and AB154 in participants with histologically diagnosed advanced or metastatic squamous cell carcinoma of the head and neck (middle pharynx, oral cavity, hypopharynx, larynx) with no prior treatment for advanced cancer.~・The validity of enrollment in the cohort must be confirmed, taking into account the patient background including CPS and the guidelines for head and neck cancer treatment.
Experimental: Cohort D-6
AB122 will be given in combination with TAS-120, Carboplatin and nab-Paclitaxel in participants with unresectable metastatic squamous NSCLC patients with no prior treatment for advanced cancer.
Experimental: Cohort D-7
AB122 will be given in combination with TAS-120, Cisplatin and Gemcitabine in participants with unresectable metastatic adenocarcinoma or adenosquamous biliary tract cancer patients with no prior treatment for advanced cancer.
Experimental: Cohort D-8
AB122 will be given in combination with TAS-120, nab-Paclitaxel and Gemcitabine in participants with unresectable metastatic Pancreatic ductal adenocarcinoma patients with no prior treatment for advanced cancer.
Sponsors
Leads: Taiho Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov