Phase 1 Lymphoma Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People with advanced solid tumors (confirmed by lab testing) that cannot be removed by surgery, where the cancer has continued to grow after at least one previous systemic treatment (such as chemotherapy) — this applies to the dose-finding stage of the trial.
- People with confirmed Hodgkin lymphoma or non-Hodgkin B-cell lymphoma (as classified by a recognised medical standard), where the cancer has continued to grow after at least two previous systemic treatments — this applies to the dose-finding stage.
- People with relapsed or treatment-resistant lymphomas or advanced solid tumors who have already tried standard treatments without success — for the monotherapy groups. Solid tumor patients in these groups must have tumours that test positive for a protein called ROR1. For combination therapy groups, people with a specific lymphoma type called DLBCL (either newly diagnosed or having tried at least one prior standard treatment), or solid tumor patients who have not previously received a type of immune therapy called PD-1/PD-L1 inhibitors and have tried at least one prior standard treatment.
- People who have at least one area of cancer that can be assessed or measured on scans, according to recognised medical measurement standards.
- People with a life expectancy of more than 3 months.
- People with a general health and activity level rated 0 to 2 on a standard medical scale (meaning able to carry out everyday activities, possibly with some limitations but not fully disabled).
- People whose liver, kidneys, and other organs are functioning well enough, as assessed by the trial team.
Who may not be able to join:
- People whose cancer could be treated with local treatments aimed at a cure, or — for lymphoma patients — those whom the doctor considers suitable for a stem cell transplant.
- People who have had another cancer that has been active within the past 3 years, unless it was a localised cancer that appears to have been fully treated.
- People who have previously taken part in another study using treatments that target the ROR1 protein — this applies to the dose-expansion stage only.
- People who have lymphoma or cancer that has spread to the brain or spinal cord, particularly if it is causing symptoms, has not been treated, or still requires active treatment.
- People with other significant ongoing medical or mental health conditions.
- People with a weakened immune system, an active autoimmune disease, or another condition that requires regular steroid medication.
- People with significant fluid build-up in the legs, around the heart, or in the abdomen that requires medical treatment or limits daily activities, or those with a known history of blood vessel problems in the limbs.
- People who have had an active infection requiring systemic treatment (such as antibiotics given by mouth or through a drip) within 2 weeks before the first dose of the study drug.
- People known to be HIV-positive or to have AIDS.
- People who have had a significant heart condition within the 6 months before the first dose of the study drug.
- People with notable abnormalities found on a heart electrical tracing (ECG) taken during screening.
- People who have had major surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other cancer treatments within 21 days before the first dose of the study drug.
- People who have received a live vaccine within 28 days before the first dose of the study drug.
- People with active graft versus host disease (a complication that can occur after a transplant).
- People with a known active problem with alcohol or drug misuse.
- People who are pregnant or currently breastfeeding.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 021-60332435
Australian sites
61 02 9382 5800
618 7074 4133
613 8560 4019
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
6 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part); Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part); Incident and severity of adverse events; Objective Response Rate (ORR) (for dose expansion)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.