Clinical trial NCT05083481: A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors
Official title: A Phase 1/2 Study of ASP1570 as Monotherapy and in Combination With Pembrolizumab and/or Standard Therapies Including Chemotherapy and/or Immunotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
Conditions: Advanced Solid Tumors
Summary: Immune therapies work with the body's immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors. However, some tumors can become resistant to attack by T-cells over time. They do this by sending "off" signals to T-cells. The researchers are finding ways to switch the T-cells back on.
Before a treatment can be approved for use, clinical studies need to be done. This study will provide more information on ASP1570 in adults with advanced solid tumors. ASP1570 will either be given by itself, or given with another medicine called pembrolizumab, given with a standard cancer therapy, or given together with pembrolizumab and other medicines called pemetrexed and carboplatin.
The main aims of this study are：
* To check the safety of ASP1570
* To check how well ASP1570 is tolerated
* To find a suitable dose of ASP1570
This study is for adults with advanced solid tumors. Their tumor has either grown outside of the area where it started (locally advanced and unresectable) or it has spread to other parts of the body (metastatic). Their cancer gets worse after standard therapy or they are unable to have standard therapy. The study doctors can give more advice about who can take part.
This study will be in 2 parts.
In Part 1, the most suitable dose of ASP1570 to give to people with advanced solid tumors will be worked out. Different small groups of people with advanced solid tumors will take lower to higher doses of ASP1570. People will either be given ASP1570 by itself, or ASP1570 with pembrolizumab, ASP1570 with a standard cancer therapy, or ASP1570 with pembrolizumab, pemetrexed and carboplatin. The study treatment given depends on the type of cancer people have. There are different doses of ASP1570, with each group staying on the same dose. There is just 1 standard dose of pembrolizumab. The dose of a standard cancer therapy depends on its label. After taking the lowest dose of ASP1570, the first group will be checked for medical problems. The next group can only take the higher dose of ASP1570 if the first group tolerates the lowest dose. This will continue in the same way for each group.
Each group will take tablets of ASP1570 either once or twice every day in a 21-day cycle. People will continue with more treatment cycles on the same dose unless they can't tolerate the study treatment, their cancer gets worse or the study doctor decides that person should stop treatment. People who also receive treatment with pembrolizumab will be infused with pembrolizumab on the first day of every other cycle of ASP1570 (once every 6 weeks). People who are receiving a standard cancer therapy (with ASP1570) will be treated according to its label.
In Part 2, different small groups of people with advanced solid tumors will take the most suitable dose of ASP1570 worked out from Part 1. The dose will not go above the highest dose that people could tolerate from Part 1. ASP1570 will be given either once a day or twice a day in a 21-day cycle. Pembrolizumab will be given once every 6 weeks. Other study treatments will be given in 14-day, 21-day or 28-day cycles. The cycle length and other study treatments given (pembrolizumab and the type of standard cancer therapy will depend on what type of tumor people have. The standard cancer therapies will be given according to their label. All groups will continue with more treatment cycles with ASP1570 (by itself with pembrolizumab, with a standard cancer therapy, or with pembrolizumab, pemetrexed and carboplatin) unless they can't tolerate the study treatment, their cancer gets worse or the study doctor decides that person should stop treatment.
Interventions:
description: Oral tablet
name: ASP1570
type: Drug
description: Intravenous Infusion
name: pembrolizumab
other_name: KEYTRUDA®
type: Drug
description: Oral Administration
name: Trifluridine + Tipiracil
other_name: TAS-102
type: Drug
description: Intravenous Infusion
name: Bevacizumab
type: Drug
description: Intravenous Infusion
name: Docetaxel
type: Drug
description: Intravenous Infusion
name: Oxaliplatin
type: Drug
description: Intravenous Infusion
name: Leucovorin
type: Drug
description: Intravenous Infusion
name: 5-Fluorouracil
type: Drug
description: Intravenous Infusion
name: Irinotecan
type: Drug
description: Intravenous Infusion
name: Pemetrexed
type: Drug
description: Intravenous Infusion
name: Carboplatin
type: Drug
Study arms:
design_group_description: Participants will receive daily dose of ASP1570 in a 21-day cycle.
design_group_title: ASP1570 Monotherapy Dose Escalation (Part 1)
design_group_type: Experimental
design_group_description: Participants will receive daily dose of ASP1570 in a 21-day cycle. pembrolizumab will be administered every 6 weeks on day 1 of every other ASP1570 cycle.
design_group_title: ASP1570 + pembrolizumab Combination therapy Dose Escalation (Part 1)
design_group_type: Experimental
design_group_description: Participants who have NSCLC will receive RP2D of ASP1570 daily in a 21-day cycle. Docetaxel will be administered every 6 weeks on day 1 of every other ASP1570 cycle.
design_group_title: ASP1570 + Docetaxel Combination therapy Dose Expansion - NSCLC 2L+ (Part 2)
design_group_type: Experimental
design_group_description: Participants will receive RP2D of ASP1570 after the meal in a 21-day cycle. This cohort will be opened at the discretion of the sponsor.
design_group_title: ASP1570 Monotherapy Dose Expansion - Food Effect (Part 2)
design_group_type: Experimental
design_group_description: Participants will receive RP2D of ASP1570 with some periodical drug holiday in a 21-day cycle. This cohort will be opened at the discretion of the sponsor.
design_group_title: ASP1570 Monotherapy Dose Expansion - Intermittent dosing (Part 2)
design_group_type: Experimental
design_group_description: Participants will receive ASP1570 administered by intra-subject dose escalation with gradual multiple dose steps (e.g., 3 steps) and increased dose up to RP2D in a 21-day cycle. This cohort will be opened at the discretion of the sponsor.
design_group_title: ASP1570 Monotherapy Dose Expansion - Stepwise dosing (Part 2)
design_group_type: Experimental
design_group_description: Participants who have MSS-CRC will receive ASP1570 in a 21-day cycle.
design_group_title: ASP1570 Monotherapy Dose Expansion Microsatellite stable - colorectal cancer (MSS-CRC) (Part 2)
design_group_type: Experimental
design_group_description: Participants who have MSS-CRC will receive ASP1570 daily in a 28-day cycle. TAS-102 (Trifluridine + Tipiracil) will be administered on days 1 through 5 and days 8 through 12 of each 28-day cycle. Bevacizumab will be administered every 2 weeks.
design_group_title: ASP1570 + TAS-102 + Bevacizumab Combination therapy Dose Expansion - MSS-CRC 3L+ (Part 2)
design_group_type: Experimental
design_group_description: Participants who have NSCLC will receive ASP1570 in a 21-day cycle.
design_group_title: ASP1570 Monotherapy Dose Expansion NSCLC (Part 2)
design_group_type: Experimental
design_group_description: Participants who have NSCLC will receive ASP1570 daily in a 21-day cycle. Pembrolizumab will be administered every 6 weeks on day 1 of every other ASP1570 cycle. Pemetrexed and carboplatin will be administered on day 1 of each 21-day cycle.<br/>Combination therapy Dose Expansion (CTDE)
design_group_title: ASP1570 + Pembrolizumab + Pemetrexed + Carboplatin CTDE - NSCLC 1L (Part 2)
design_group_type: Experimental
design_group_description: Participants who have MSS-CRC will receive ASP1570 in a 14-day cycle. Bevacizumab, will be administered every 2 weeks. mFOLFOX6 (oxaliplatin, Leucovorin, 5-fluorouracil) or FOLFIRI (Leucovorin, 5-Fluorouracil, Irinotecan) will administered every 2 weeks.
design_group_title: ASP1570 + Bevacizumab + mFOLFOX6 or FOLFIRI Combination therapy Dose Expansion - MSS-CRC 2L (Part 2)
design_group_type: Experimental
Sponsor: Astellas Pharma Global Development, Inc.
Collaborators: Merck Sharp & Dohme LLC
Drug name mappings:
name: 曲氟尿苷替匹嘧啶
lang: CN
name: Tipiracil Hydrochloride/Trifluridine
lang: EN
name: トリフルリジン/チピラシル塩酸塩
lang: JP
name: ASP-1570
lang: EN
name: 亚叶酸钙
lang: CN
name: Leucovorin Calcium
lang: EN
name: ホリナートカルシウム
lang: JP
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 培美曲塞二钾
lang: CN
name: Pemetrexed Dipotassium
lang: EN
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP
name: 贝伐珠单抗
lang: CN
name: Bevacizumab
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
name: 盐酸伊立替康
lang: CN
name: Irinotecan Hydrochloride
lang: EN
name: イリノテカン塩酸塩水和物
lang: JP
name: 奥沙利铂
lang: CN
name: Oxaliplatin
lang: EN
name: オキサリプラチン
lang: JP
name: 氟尿嘧啶
lang: CN
name: Fluorouracil
lang: EN
name: フルオロウラシル
lang: JP