SAIL66 for Solid Tumors

Not currently recruiting at 9 trial locations

Overseen By Clinical trials information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Chugai Pharmaceutical

Disqualifiers: CNS disease, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SAIL66 for individuals with certain advanced solid tumors. The goal is to assess the safety and tolerability of SAIL66 and understand its effects on the body. Participants will receive SAIL66 through an IV, either weekly or every three weeks, to determine the optimal dose. The trial seeks individuals whose tumors test positive for CLDN6 and who do not have issues like uncontrolled pain or certain brain conditions. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that SAIL66 is likely to be safe for humans?

Research shows that SAIL66, a treatment targeting specific proteins on cancer cells, is in early testing to assess its safety for humans. These studies examine how SAIL66 interacts with certain proteins to help the body combat tumors. As an early-stage study, the primary focus is on evaluating how well participants tolerate the treatment and identifying any side effects.

Due to the absence of earlier or larger studies, early-stage trials prioritize finding the safest dose and understanding potential side effects. The treatment's safety remains under investigation, and participants might experience side effects, which is common in early trials. Safety information continues to be collected, so prospective participants should be well-informed and discuss any concerns with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solid tumors, which often rely on chemotherapy or targeted therapies, SAIL66 is unique because it leverages a novel mechanism of action that specifically targets tumor cells. Researchers are excited about its potential due to its innovative delivery method, being administered through IV infusions either weekly or tri-weekly, which allows for flexible dosing and potentially improved patient outcomes. This approach not only aims to maximize effectiveness by tailoring the dosage but also minimizes the impact on healthy cells, potentially leading to fewer side effects compared to traditional options.

What evidence suggests that SAIL66 might be an effective treatment for solid tumors?

Research shows that SAIL66, a new treatment under study in this trial, targets a protein called CLDN6 found in some solid tumors. Animal studies have demonstrated that SAIL66 can increase the number of active immune cells in tumors and reduce the number of tired immune cells. This suggests that SAIL66 might help the body's immune system fight cancer more effectively. The treatment aims to help the immune system attack cancer cells more aggressively. These early results are promising for patients with CLDN6-positive tumors. Participants in this trial will receive SAIL66 in different dosing schedules, including weekly and tri-weekly infusions, to evaluate its effectiveness and safety. ^{1 2 3 4 6}

Who Is on the Research Team?

Sponsor Chugai Pharmaceutical Co. Ltd

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

Adults over 18 with CLDN6-positive advanced or metastatic solid tumors can join this trial. They must be in good physical condition, meaning they're fully active or have some symptoms but can still do light work (ECOG PS of 0 or 1). A tumor sample for review is also required.

Inclusion Criteria

My tumor is CLDN6 positive.

I am fully active or can carry out light work.

Exclusion Criteria

I have pain from my cancer that isn't relieved by treatment.

I do not have uncontrolled fluid buildup in my chest, heart, or abdomen.

Intending to become pregnant or breastfeed during the study and within 3 months after the last dose of SAIL66 or tocilizumab, whichever is longer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive SAIL66 as IV infusions at escalated doses, with or without obinutuzumab premedication

18 weeks

Weekly or tri-weekly visits

Expansion

Participants receive SAIL66 at the recommended dose to evaluate safety and efficacy

18 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAIL66

Trial Overview

The study tests SAIL66's safety and how well it works in patients. It starts by giving small doses to a few people and slowly increasing the amount. Researchers will watch how the body reacts to it (PK/PD) and if it helps shrink the tumors.

How Is the Trial Designed?

Group I: QW Dose Escalation part Experimental Treatment 1 Intervention

Patients will receive SAIL66 as a weekly IV infusion at escalated doses.

Group II: Q3W Dose Escalation part Experimental Treatment 1 Intervention

Patients will receive SAIL66 as tri-weekly IV infusions at escalated doses.

Group III: Expansion part Experimental Treatment 1 Intervention

Patients will receive SAIL66 as a IV infusion at the recommended dose.

Who Is Running the Clinical Trial?

Chugai Pharmaceutical

Lead Sponsor

Trials

105

Recruited

25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University

Published Research Related to This Trial

TP53 is a crucial tumor suppressor gene that, when mutated, can lead to both loss-of-function and gain-of-function effects, contributing to cancer progression and metastasis, making it a key target for cancer therapies.

Current strategies for targeting TP53 in cancer treatment include enhancing p53 activity, restoring p53 pathway function in tumors with mutations, utilizing p53 in immunotherapy, and exploring combination therapies that target both wild-type and mutant p53.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Strategies for Therapeutic Targeting of Wild-Type and Mutant p53 in Cancer. Zhang, S., Carlsen, L., Hernandez Borrero, L., et al.[2022]

A novel zebrafish model was developed to study Ewing sarcoma, allowing for effective screening of treatments and quantification of tumor progression, particularly focusing on the EWSR1-FLI1 fusion protein.

Combining Nutlin-3, which reactivates the p53 pathway, with YK-4-279, which blocks EWSR1-FLI1 activity, showed enhanced inhibition of tumor growth in TP53 wild-type Ewing sarcoma cells, suggesting a promising therapeutic strategy for this subtype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ewing sarcoma inhibition by disruption of EWSR1-FLI1 transcriptional activity and reactivation of p53. van der Ent, W., Jochemsen, AG., Teunisse, AF., et al.[2019]

Sustained mutant p53 is essential for the maintenance of tumors, indicating its critical role in cancer progression.

Targeting mutant p53 presents a promising therapeutic strategy for cancer treatment, as it could disrupt tumor survival mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Destabilization of Mutant p53 Proteins Suppresses Tumor Growth. [2015]

Gene therapy using wild-type p53 delivered by adenovirus vectors is widely used in China and represents a promising approach to target cancer cells that have inactivated p53 functions.

New strategies, including oncolytic viruses and small molecules that activate p53, are being developed to enhance cancer treatment efficacy while potentially protecting normal cells, indicating a shift towards more targeted and safer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

p53-based cancer therapy. Lane, DP., Cheok, CF., Lain, S.[2022]

The combination of the YB-1-driven oncolytic adenovirus XVir-N-31 and CDK4/6 inhibition significantly enhances the immune response against Ewing sarcoma (EwS), leading to increased viral replication and tumor cell destruction in both laboratory and animal models.

This treatment approach not only improves local tumor control but also boosts systemic immunity, as evidenced by enhanced T-cell activation and improved survival rates in preclinical studies, suggesting strong potential for clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Oncolytic Adenovirus XVir-N-31 Joins Forces with CDK4/6 Inhibition Augmenting Innate and Adaptive Antitumor Immunity in Ewing Sarcoma. Schober, SJ., Schoening, C., Eck, J., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11474890/

SAIL66, a next generation CLDN6-targeting T-cell engager ...

In vivo studies demonstrated that SAIL66 led to a more pronounced increase in intratumor T-cell infiltration and a decrease in exhausted T cells ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05735366

NCT05735366 | A Phase 1 Study of SAIL66 in Patients ...

This is a Phase 1 dose-escalation and expansion study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary ...

3.

jitc.bmj.com

jitc.bmj.com/content/jitc/12/10/e009563.full.pdf

SAIL66, a next generation CLDN6-targeting T-cell engager ...

Conclusion Our data demonstrate that SAIL66, designed to engage. CLDN6, CD3, and CD137, has the potential to enhance antitumor activity and provide a potent ...

4.

chugai-pharm.co.jp

chugai-pharm.co.jp/english/news/detail/20241024170000_1110.html

Chugai's SAIL66, under Development for CLDN6 Positive ...

The following findings were demonstrated in this research, which suggest that SAIL66 may be useful as a treatment for CLDN6 positive solid ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39401967/

SAIL66, a next generation CLDN6-targeting T-cell engager ...

In vivo studies demonstrated that SAIL66 led to a more pronounced increase in intratumor T-cell infiltration and a decrease in exhausted T cells ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-phase-1-study-of-sail66-in-patients-with-cldn6-positive-locally-advanced-or-metastatic-solid-tumor

A Phase 1 Study of SAIL66 in Patients With CLDN6-positive ...

This is a Phase 1 dose-escalation and expansion study that will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics ...