AT-1965 for Cancer

Recruiting at 6 trial locations

Overseen By Eldho Jose

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Alyssum Therapeutics

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Uncontrolled diabetes, Autoimmune disease, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 2

85 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a first-in-human, multicenter, open-label, dose escalation and dose expansion Phase 1/2 study to determine the MTD and/or the recommended Phase 2 dose (RP2D) and to characterize DLTs of AT-1965 as well as to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of AT-1965 in patients with advanced, refractory or recurrent solid tumors (nonresectable and/or metastatic) including mTNBC.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

Is the drug AT-1965 a promising treatment for cancer?

The drug AT-1965 is considered promising for cancer treatment because it offers hope for improving survival rates, especially in older patients who generally have lower survival rates. Advances in cancer treatments have historically led to better outcomes, and AT-1965 could be part of this positive trend. ^{1 2 3 4 5}

Research Team

Richard Fahrner, PhD

Principal Investigator

Alyssum Therapeutics

Eligibility Criteria

This trial is for adults with advanced solid tumors that are not removable by surgery or have spread, and which haven't responded to standard treatments. Participants must have recovered from previous treatment side effects (except hair loss) and should be relatively fit (ECOG status of 0 or 1). They need at least one tumor that can be measured on scans, adequate blood counts, kidney function, and liver enzymes within certain limits.

Inclusion Criteria

My kidney, liver, and bone marrow are functioning well.

It has been at least 28 days since my last COVID-19 mRNA vaccine shot.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

My hormone levels are stable with my current treatment.

Patients with a history of autoimmune disease. Excluded autoimmune conditions are listed in the Protocol Appendix 1

I have a serious heart condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation Phase

Participants receive escalating doses of AT-1965 to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).

28 days per cycle

Visits on Days 1, 8, and 15 of each cycle

Dose Expansion Phase

Participants receive the recommended Phase 2 dose to further evaluate safety and preliminary antitumor activity.

28 days per cycle

Visits on Days 1, 8, and 15 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AT-1965

Trial Overview The study tests AT-1965 Liposome Injection in patients with tough-to-treat solid tumors. It's a Phase 1/2 trial aiming to find the highest dose patients can take without serious side effects (MTD), decide on a recommended dose for future studies (RP2D), understand how the drug behaves in the body (PK/PD), and see if it shrinks tumors.

Participant Groups

Group I: AT-1965 Liposome Injection Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Alyssum Therapeutics

Lead Sponsor

Trials

1

Recruited

90+

CBCC Global Research

Collaborator

Trials

8

Recruited

1,300+

Findings from Research

Cancer incidence rates are significantly higher in individuals aged 65 and older, with rates for older males being four times and for older females being twice that of younger age groups (45 to 64 years).

Despite higher incidence rates, the relative survival rates for older patients (65+) are only slightly lower than those for younger patients (45 to 64), indicating that older patients generally have similar outcomes once diagnosed, except for certain cancers like urinary bladder and non-Hodgkin's lymphomas where survival rates are notably lower.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer incidence and survival in patients 65 years of age and older. Baranovsky, A., Myers, MH.[2019]

Cancers diagnosed in Saskatchewan between 1967 and 1986 showed high 15-year relative survival rates for certain types, such as lip cancer and melanoma in women, indicating effective treatment outcomes for these cancers.

Survival rates improved for cases diagnosed between 1980-1984 compared to those from 1970-1974 across various cancer types, with stage at diagnosis being a crucial factor for colorectal cancer survival, more so than age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival rates among patients with cancer in Saskatchewan, 1967-1986. Mao, Y., Robson, D., Semenciw, RM., et al.[2018]

Cancer incidence in adolescents and young adults (ages 15-30) is 2.7 times higher than in younger children, but still accounts for only 2% of all invasive cancers, with specific types like Hodgkin lymphoma and melanoma being most common.

Survival rates for young adults diagnosed with cancer have not improved over the past 25 years, with males and certain racial groups, such as African Americans, experiencing worse prognoses compared to non-Hispanic whites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer in 15- to 29-year-olds by primary site. Bleyer, A., Viny, A., Barr, R.[2015]

Survival rates for lymphoma and leukemia patients significantly improved from 1950 to 1973, with the most notable increase seen in acute lymphocytic leukemia, while chronic granulocytic leukemia showed the least improvement.

Cancer mortality rates decreased by 20% for individuals up to 45 years old, but there was an 8% increase in mortality for those over 55, highlighting a complex trend in cancer outcomes across different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of cancer therapy on survival. Stonehill, EH.[2019]

In a study of 57,068 women diagnosed with breast cancer in Sweden from 1960 to 1978, those aged 45 to 49 had the best relative survival rates, outperforming younger patients by up to 12.9% over time.

Relative survival rates significantly declined for women over 49, especially for those over 75, indicating that older age is associated with worse long-term outcomes in breast cancer, with mortality rates exceeding 5% in the oldest age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relation between survival and age at diagnosis in breast cancer. Adami, HO., Malker, B., Holmberg, L., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cancer incidence and survival in patients 65 years of age and older. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Long-term survival rates among patients with cancer in Saskatchewan, 1967-1986. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Cancer in 15- to 29-year-olds by primary site. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of cancer therapy on survival. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The relation between survival and age at diagnosis in breast cancer. [2022]