Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Summit Therapeutics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1_Chemotherapy Regimen Selection Stage Group A(AK112+AK117+XELOX) | Experimental | AK112+AK117+XELOX AK112 and AK117 and XELOX(Oxaliplatin 130 mg/sqm iv day 1, Capecitabine via oral, the total daily dose was 2000mg/sqm, day1-14) If no progression occurs during AK112 plus AK117 plus XELOX, patients will receive maintenance capecitabine plus AK112 plus AK117 at the same dose used at the last cycle of the induction treatment. Capecitabine plus AK112 plus AK117 will be repeated every 3 weeks until disease progression, unacceptable toxicity or patient's refusal. |
|
| Part 1_Chemotherapy Regimen Selection Stage Group B(AK112+AK117+FOLFOXIRI) | Experimental | AK112+AK117+FOLFOXIRI AK112 and AK117 and FOLFOXIRI(Irinotecan 150-165 mg/sqm iv day 1, Oxaliplatin 85 mg/sqm iv day 1, Leucovorin(LV) 400 mg/sqm iv day 1, 5-fluorouracil(5-FU) 2400-2800 mg/sqm 46-48 hours continuous infusion, starting on day 1) If no progression occurs during AK112 plus AK117 plus FOLFOXIRI, patients will receive maintenance 5-FU/LV plus AK112 plus AK117 at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus AK112 plus AK117 will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal. |
|
| Part 1_Expansion Stage Group A(AK112 DS1+Chemotherapy) | Experimental | AK112 (Dose1) +Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112 | Drug | AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rates (ORR) | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1 | Up to approximately 2 years |
| Number of participants with adverse events (AEs) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1 | Up to approximately 2 years |
| Duration of response (DOR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Summit Therapeutics Research Site | Los Angeles | California | 90067 | United States | ||
| Summit Therapeutics Research Site |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D000077146 | Irinotecan |
| D002955 | Leucovorin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Part 1_Expansion Stage Group B(AK112 DS1+AK117 DS1+Chemotherapy) | Experimental | AK112 (Dose1) +AK117 (Dose1) +Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and AK117 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage) |
|
| Part 1_Expansion Stage Group C (AK112 DS2+Chemotherapy) | Experimental | AK112 (Dose2)+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage). AK112 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage). |
|
| Part 1_Expansion Stage Group D (AK112 DS2 +AK117 DS2 +Chemotherapy) | Experimental | AK112(Dose2) + AK117(Dose2)+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and AK117 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage) |
|
| Part 1_Expansion Stage Group E (AK112 DS2+AK117 DS1+Chemotherapy) | Experimental | AK112(Dose2)+AK117(Dose1)+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage) AK112 and AK117 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage) |
|
| Part 1_Extension Stage Group F (AK112 DS1 + mFOLFOX6) | Experimental | AK112 (Dose1) +mFOLFOX6 ( Oxaliplatin 85 mg/sqm IV day 1, Leucovorin 400 mg/sqm IV day 1, 5-fluorouracil(5-FU) 2400 mg/sqm 46-48 hours continuous infusion, starting on day 1). If no progression occurs during AK112 plus mFOLFOX6, patients will receive maintenance 5- FU/LV plus AK112 at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus AK112 will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal. |
|
| Part 1_Extension Stage Group G (AK112 DS2+mFOLFOX6) | Experimental | AK112 (Dose2) +mFOLFOX6 ( Oxaliplatin 85 mg/sqm IV day 1, Leucovorin 400 mg/sqm IV day 1, 5-fluorouracil(5-FU) 2400 mg/sqm 46-48 hours continuous infusion, starting on day 1) If no progression occurs during AK112 plus mFOLFOX6, patients will receive maintenance 5- FU/LV plus AK112 at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus AK112 will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal. |
|
| Part 2 cohort 1(AK112) | Experimental | Subjects receive AK112 until disease progression or unacceptable toxicity AK112 (until disease progression, unacceptable toxicity or patient's refusal) |
|
| Part 2 cohort 2(AK112+AK117) | Experimental | Subjects receive AK117 and AK112 until disease progression or unacceptable toxicity AK112 and AK117 ( until disease progression, unacceptable toxicity or patient's refusal) |
|
| AK117 | Drug | AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity |
|
| Oxaliplatin | Drug | Oxaliplatin via IV infusion |
|
| Capecitabine | Drug | Capecitabine via oral,The total daily dose was 2000mg/sqm, Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days |
|
| Irinotecan | Drug | Irinotecan via IV infusion |
|
| Leucovorin | Drug | Leucovorin via IV infusion |
|
| 5-fluorouracil | Drug | 5-fluorouracil via IV infusion |
|
DOR is defined for participants who had an objective response as the time from the first occurrence of a documented confirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause,whichever occurred first
| Up to approximately 2 years |
| Time to response (TTR) | TTR is defined for participants who had an objective response as the time from the start of treatment to the first occurrence of a documented unconfirmed response (CR or PR) . | Up to approximately 2 years |
| Progression-free survival (PFS) | PFS is defined as the time from the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first). | Up to approximately 2 years |
| Progression-free survival 2 (PFS2) | PFS 2 is defined as the time from the start of treatment till the second documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first). | Up to approximately 2 years |
| Overall survival (OS) | Overall survival is defined as the time from the start of treatment until death due to any cause. | Up to approximately 2 years |
| Murrieta |
| California |
| 92562 |
| United States |
| Summit Therapeutics Research Site | Fairfax | Virginia | 22031 | United States |
| The Sixth Hospital,Sun Yat-sen University | Guanzhou | Guangdong | 510000 | China |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |