Phase 1 Lymphoma Trial, Recruiting NCT05279300 Sponsor: CStone Pharmaceuticals Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT05279300
Recruiting Phase 1 🇦🇺 Australian site

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 021-60332435

Australian sites

Scientia Clinical Research Limited, Randwick, New South Wales
61 02 9382 5800
Ashford Cancer Centre Research, Adelaide, South Australia
Central Adelaide Local Health Network Incorporated, Adelaide, South Australia
Royal Adelaide Hospital (RAH), Adelaide, South Australia
618 7074 4133
Epworth Freemasons Medical Centre, East Melbourne, Victoria
613 8560 4019
Epworth Foundation trading as Epworth HealthCare, Melbourne, Victoria

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

Status
Recruiting
Phase
Phase 1
Sponsor
CStone Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
28 March 2022
Est. completion
30 June 2027

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇺🇸 United States

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?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov